Identity
- Trade Name
- Diamodent FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Compatible with: 5.0mm external hex BIOMET 3i implants Threaded Impression Coping, Titanium Open Tray, 6mm Profile FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- Compatible with: 5.0mm external hex BIOMET 3i implants Threaded Impression Coping, Titanium Open Tray, 6mm Profile FDA UDI
Identifiers
- Catalog Number
- C750 FDA UDI
- Primary DI / UDI-DI
- D907C7500 FDA UDI
- 510(k) Number
- K010619 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, reusable
Diamodent by Diamodent — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, reusable.
- Snappy™ — Nobel Biocare AG · Class I
- X-Nav FastMap Scan Body — Elos Medtech Pinol A/S · Class I
- MEDENTiKA — Medentika GmbH · Class I
- ZZ BASE NB-R-WMSM-L12 5.0 (White Metal Scanmarker L12 with Screw) — Zirkonzahn GmbH · Class I
- ZZ BASE S-S-WMSM-L12 3.3 (White Metal Scanmarker L12 with Screw) — Zirkonzahn GmbH · Class I
- ZZ BASE DO-B-ICSC NC (Impression coping Screw) — Zirkonzahn GmbH · Class I
- DS Implants — Dentsply Implants Manufacturing GmbH · Class I
- ZZ BASE S&M-PR-ICSC 3.8 - 4.25 - 5.0 (Impression coping Screw) — Zirkonzahn GmbH · Class I
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diamodent
Sources (1)
- FDA UDI 32f2cae1-82fc-49c2-8945-26fc7c8f3591 35 fields · synced May 30, 2026