Identifiers
- 510(k) Number
- K220366 FDA 510(k)
- FDA Product Code
- DZJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4120 FDA 510(k)
- Regulation Number
- 872.4120 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
EmbedMed is a manual driver, wire, and bone drill device classified under FDA device class 2. It is substantially equivalent to a predicate device and has received traditional 510(k) clearance (K220366). The device is intended for dental use, as indicated by the advisory committee designation and medical specialty description.
EmbedMed is supplied as a non-sterile, reusable device for use in dental clinical settings. It does not have MRI safety information specified in the data. The device is manufactured by 3D Lifeprints UK, Ltd., and its regulatory status is based on FDA 510(k) clearance under product code DZJ and regulation number 872.4120. No information on sizes, storage, or single-use designation is provided in the data.
Frequently asked questions
What is the EmbedMed device intended for?
The EmbedMed device is intended for dental use, as indicated by its advisory committee designation and medical specialty description in the FDA 510(k) submission.
How is the EmbedMed device supplied and is it sterile or reusable?
EmbedMed is supplied as a non-sterile, reusable device for use in dental clinical settings, meaning it must be cleaned and sterilized by the user before each use.
What regulatory clearance does the EmbedMed device have?
EmbedMed has received traditional 510(k) clearance from the FDA under submission number K220366, confirming it is substantially equivalent to a predicate device.
What is the product code and regulation number for the EmbedMed device?
The EmbedMed device is classified under FDA product code DZJ and regulation number 872.4120, which governs manual driver, wire, and bone drill devices.
Does the EmbedMed device come in different sizes or have MRI safety information?
No information on sizes, storage, single-use designation, or MRI safety is provided in the device data for EmbedMed.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K221943 FDA 510 (k) - EmbedMed | 3D Lifeprints UK , Ltd., K220366 - EmbedMed | FDA 510(k) | 3D Lifeprints UK , Ltd., 3D LIFEPRINTS UK LTD - RevMed, EmbedMed - BEUDAMED, EmbedMed 510 (k) K221943 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220366 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3D Lifeprints UK , Ltd.
Sources (1)
- FDA 510(k) K220366 24 fields · synced Sep 26, 2026