Identity
- Trade Name
- Implantswiss FDA UDI
- Generic Name
- Dental drill bit extension FDA UDI
- Device Name
- Drill Extension Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Instruments dedicated to implant system for the support of dental prostheses. FDA UDI
- Model / Reference
- S-D/E FDA UDI
- Description
- Drill Extension Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Instruments dedicated to implant system for the support of dental prostheses. FDA UDI
Identifiers
- Catalog Number
- S-D/E FDA UDI
- Primary DI / UDI-DI
- 07630188201772 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental drill bit extension FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental drill bit extension
Implantswiss by Novodent SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental drill bit extension.
- Dríva™ Gold Series Drills — BIOMET 3I, LLC · Class I
- Zuga — Zuga Medical, Inc. · Class II
- Restore — Keystone Dental Inc. · Class II
- Drill Extension — Ossvis Co., Ltd. · Class I
- A. Titan Instruments — A.Titan Instruments · Class I
- Tapered Screw-Vent® — ZIMMER DENTAL INC. · Class I
- Mount Extension — POINTIMPLANT Co., Ltd. · Class I
- Tapered Screw-Vent® — ZIMMER DENTAL INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Novodent SA
Sources (1)
- FDA UDI ba57dd16-bff1-4c14-ae19-87c605962cc0 34 fields · synced Jun 8, 2026