Identity
- Trade Name
- G-Stop Keys-Large-8mm FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Provides vertical control for drilling the osteotomy. The G-Stop Gauges and G-Stop Keys can be used with printed guides to control the angulation of the hole FDA UDI
- Model / Reference
- VTSP-L-O-8 FDA UDI
- Description
- Provides vertical control for drilling the osteotomy. The G-Stop Gauges and G-Stop Keys can be used with printed guides to control the angulation of the hole FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017652408 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant system
G-Stop Keys-Large-8mm by Versah, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
- Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
- Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
- Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
- Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · Class II
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
- Versah, Llc
Sources (1)
- FDA UDI d4af454c-8498-47a5-ab23-33e66d91f125 34 fields · synced May 30, 2026