Identity
- Trade Name
- Implantswiss FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Hex Machine Driver Short 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-12HDMS FDA UDI
- Description
- Hex Machine Driver Short 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-12HDMS FDA UDI
- Primary DI / UDI-DI
- 07630188201598 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Surgical screwdriver, reusable 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: Surgical screwdriver, reusable
Implantswiss by Novodent SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novodent SA
Sources (1)
- FDA UDI 9d024585-5d40-475c-b79e-a4baa4879ff5 34 fields · synced May 30, 2026