Quality & compliance
Everything we claim here, you can ask us to prove.
A custom-made restoration sits on a regulatory pathway most practices have never had explained to them, and most laboratories are happy to leave it that way. What follows is what the law actually asks — including the parts that are commonly overstated — what we do about each one, and what travels with your case.
The regulation, in full
What the law actually asks of a laboratory.
01 · FDA
United States
FD&C Act · 21 CFR Parts 820 & 872
- 01
A restoration is a custom device, not a product
Every case is made for one named patient, to the written prescription of a licensed dentist, and is not offered for general sale. That is what places it on the custom-device pathway rather than the 510(k) pathway — a crown is not cleared, it is prescribed. The prescription is the legal foundation of the whole case, which is why the portal will not open one without it.
- 02
Custom does not mean unregulated
The custom-device pathway exempts a device from premarket clearance. It exempts nobody from quality systems, labelling, traceability, complaint handling or adverse-event reporting. The FDA has made that point forcefully against laboratories that treated the exemption as a blanket one, and it is why our quality system is built on the requirements of 21 CFR Part 820 whether or not a registration is required of us.
- 03
Only cleared materials touch a patient
The zirconia, lithium disilicate, alloys, resins and cements we work in are FDA-cleared dental materials from named manufacturers. We record the manufacturer, product and lot number of every patient-contact material on the case before it ships, and the portal will not dispatch a case with that record empty.
- 04
Where your case is made, on the case
Manufacturing is carried out by Lumina Dental Laboratory at its laboratory in Egypt, under our specification and our quality system. It is the only bench we use, and we are not shopping your case to whoever is cheapest this week. Twelve states regulate dental laboratories, and several require the point of origin and the material content of a restoration to be disclosed to the prescribing dentist. We put both on every case whether your state asks for it or not — you should not have to ask your laboratory where your work was made.
- 05
Patient information is handled as PHI
A prescription, a scan and a patient reference are protected health information, and your practice is the covered entity. We act as your business associate. Before we accept PHI we sign a business associate agreement with your practice, and our manufacturing partner is bound by a subcontractor agreement carrying the same obligations. Both are drafted and with counsel — ask us for their current status before you send a case. We ask for the minimum that makes a restoration fit — a chart reference is enough. We do not need a date of birth or an insurance number, and do not want them.
Travels with every case
- Pouch label naming the laboratory that made the case
- Case number, traceable to the full record in your portal
- The prescribing dentist and the patient reference on the case
- Materials — manufacturer, product and lot number — on the case record in your portal
All of this is recorded against the case in your dashboard, so it is retrievable years later without asking us for a copy. A printable statement of materials is not yet enclosed with the shipment — the record is in the portal.
Where your case is made
Your work is manufactured by Lumina Dental Laboratory, in Egypt. We would rather you read that here than find it on a packing slip.
Benchside is not a bench with a website. It is a named bench, a fixed standard and a record you can audit. Lumina Dental Laboratory has been making restorations since 1991; we set the specification, review every case before it enters production, and carry the warranty ourselves. The laboratory is named on your case, on your documentation, and on this page.
It is the only bench we use. We are not a broker moving your case to whichever laboratory is cheapest this week. One bench, one standard, and one company answerable for it.
Offshore manufacturing is legal, common and — done in the open, with traceable materials and a named laboratory — entirely unremarkable. What is not acceptable is a laboratory that will not tell you. Ask any laboratory quoting you where the case is milled and who mills it. The answer, and how readily it comes, tells you most of what you need to know.
What that means in practice
- One bench — the same laboratory, case after case
- The manufacturing laboratory is named on every case record
- Point of origin ships with the work, in every state
- Materials are cleared, named and recorded by lot
- Protected health information crosses a border, and we say so
- A subcontractor agreement carrying the same obligations, drafted and with counsel
- The warranty is ours — you claim against Benchside, not Egypt
- Duties and freight are ours; the price we quote you is the price
How patient data is handled on that journey — what we ask for, what we refuse to collect, and what leaves the country — is set out in the privacy notice.
Standards
The documents the bench is run against.
21 CFR 820
Quality System Regulation
The FDA's requirements for device manufacturing: design control, process control, traceability, complaint handling and corrective action. Our quality system is built on these requirements. We have not been audited against them by a certification body, and we do not claim to have been.
21 CFR 872
Dental devices
The classification regulations covering dental devices, including the ceramics, alloys and resins a restoration is made from. It is the reason we buy from named manufacturers and keep the lot number, rather than buying whatever is cheapest that month.
HIPAA
Business associate obligations
45 CFR Parts 160 and 164. Before we accept PHI we sign a business associate agreement with your practice, and our manufacturing partner is bound by a subcontractor agreement carrying the same obligations. Both are drafted and with counsel.
Traceability
Lot-level material records, per case
Every patient-contact material is recorded against the case with its manufacturer, product name and lot number before dispatch. If a batch is ever recalled, we can tell you which patients are affected in minutes rather than weeks.
Point of origin
Disclosed on every case
Where the case was manufactured, stated as a matter of course on the case record and on the documentation that ships with it. Several states require this of a laboratory. We would do it regardless, because a practice that has to ask is already wondering.
Badges, honestly
What each mark is actually worth.
| Badge | What it actually means | Why it matters |
|---|---|---|
| Statement of materials | Manufacturer, product and lot number for every patient-contact material on the case. | It is what makes a recall answerable, and what several state dental practice acts expect a laboratory to produce on request. |
| Point of origin | Where the case was manufactured, named on the case record and on the pouch label that ships with it. | Some states require the disclosure. Every patient deserves it, and a laboratory unwilling to give it is telling you something. |
| Business associate agreement | The written agreement that lets your practice lawfully disclose protected health information to us. | Without one in place, a covered entity sending PHI to a vendor has a problem — and it is the practice's problem, not the vendor's. |
| Case record | Scans received, review decision, technician, materials, photographs and dispatch — kept and readable in your portal. | When a restoration is questioned months later, the argument is settled by the record, or it is settled by whoever is more confident. |
The useful test on any laboratory, including this one: ask which certification body issued the certificate, what its scope covers, and when it was last audited. A mark that cannot answer those three questions is a graphic, not a credential.
Next
The documentation is only useful if you can find it later.
Every record and photograph is attached to the case in your dashboard, alongside the scans we received and the review decision we made.