Identity
- Trade Name
- SURGICAL INSTRUMENTATION FDA UDI
- Generic Name
- Dental implant/prosthesis surgical procedure kit FDA UDI
- Device Name
- TOOL FDA UDI
- Model / Reference
- HSD FDA UDI
- Description
- TOOL FDA UDI
Identifiers
- Catalog Number
- HSD FDA UDI
- Primary DI / UDI-DI
- 07290110723095 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant/prosthesis surgical procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 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
No
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
Yes
FDA UDI
Liquid Chemical FDA UDI
Category: Dental implant/prosthesis surgical procedure kit
Surgical Instrumentation by Hi-Tec Implants — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant/prosthesis surgical procedure kit.
- STOP FOR CYLINDRICAL DRILL — SWEDEN & MARTINA INC · Class I
- RIGHT ANGLE BONE TAP — SWEDEN & MARTINA INC · Class I
- MILLABLE CRCO ABUTMENT — SWEDEN & MARTINA INC · Class I
- ANALOGUE FOR ABUTMENT — SWEDEN & MARTINA INC · Class I
- Guided Surgery — BICON, LLC · Class I
- ROUND TIP OSTEOTOME FOR GLOBAL — SWEDEN & MARTINA INC · Class I
- Zuga — Zuga Medical, Inc. · Class II
- Zuga — Zuga Medical, Inc. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hi-Tec Implants
Sources (1)
- FDA UDI df473374-f712-46f3-9014-8c43e281e368 34 fields · synced May 31, 2026