Identity
- Trade Name
- KONTACT S FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Short titanium base H 4.0 mm for Ø3mm implant +K30VP screw FDA UDI
- Model / Reference
- K30PCADCAM40 FDA UDI
- Description
- Short titanium base H 4.0 mm for Ø3mm implant +K30VP screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701045237969 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
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
No
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 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 1f16e269-1df8-44d3-8568-d6e6edb10d79 35 fields · synced Jun 8, 2026