Identity
- Trade Name
- KONTACT S FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Implant Ø3.6mm L12mm FDA UDI
- Model / Reference
- K3612S FDA UDI
- Description
- Implant Ø3.6mm L12mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701045230281 FDA UDI
- 510(k) Number
- K213997 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Dental implant system
Kontact S by Biotech Dental — Class II — 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
Cleared under the same submission
K213997 also covers:
- KONTACT — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
- KONTACT S — BIOTECH DENTAL
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
- Biotech Dental
Sources (1)
- FDA UDI de215f80-1d9d-493f-84f3-0a6c284b1f70 35 fields · synced May 30, 2026