Identity
- Trade Name
- BIONNOVATION FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- PARALLEL PINSP 2,1/2,7 MM FDA UDI
- Model / Reference
- 13106 FDA UDI
- Description
- PARALLEL PINSP 2,1/2,7 MM FDA UDI
Identifiers
- Catalog Number
- 13106 FDA UDI
- Primary DI / UDI-DI
- 07899943601091 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental implantation depth/angle gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implantation depth/angle gauge, reusable
Bionnovation by Bionnovation Produtos Biomedicos Ltda. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implantation depth/angle gauge, reusable.
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- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Parallel Pin — OSSTEM IMPLANT Co., Ltd. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Tatum Socket Guide 4.5mm — SUNCOAST DENTAL, INC. · 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
- Bionnovation Produtos Biomedicos Ltda.
Sources (1)
- FDA UDI 1340e933-e1da-4dbc-9e0e-705069c1bba7 34 fields · synced May 29, 2026