Identity
- Trade Name
- IMPLANOVA FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Model / Reference
- RDHM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007860539 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant system 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Dental implant system
The IMPLANOVA device is a dental implant system designed for surgical placement in the alveolar and/or basal bone of the mandible or maxilla. It features a sterile endosteal dental implant, abutment, and surgical instruments for implantation.
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 |
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Manufacturer
- Manufacturer
- Dental Evolutions, Inc.
Sources (1)
- FDA UDI ef92d50e-c344-41a0-8bbd-bde7182f6908 32 fields · synced Jul 26, 2026