Identity
- Trade Name
- KONTACT FDA UDI
- Generic Name
- Dental implant extractor FDA UDI
- Device Name
- Drill bit for implant removal Ø4.8mm FDA UDI
- Model / Reference
- KTEI48 FDA UDI
- Description
- Drill bit for implant removal Ø4.8mm FDA UDI
Identifiers
- Catalog Number
- KTEI48 FDA UDI
- Primary DI / UDI-DI
- 03701045242291 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant extractor 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant extractor
Kontact by Biotech Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant extractor.
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- INTERNA® FRACTURED SCREW DRILL — BIOTECHNOLOGY INSTITUTE SL · Class I
- Explantation drill — Thommen Medical AG · Class I
- SIC invent Dental Implant Systems — SIC invent AG · 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
- Biotech Dental
Sources (1)
- FDA UDI 538fca47-9450-4225-89b4-e85a455cc0c3 35 fields · synced May 30, 2026