Identity
- Trade Name
- Salvin Dental Specialties FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Manual Handle For Autotome FDA UDI
- Model / Reference
- AUTOTOME-MAN-HANDLE FDA UDI
- Description
- Manual Handle For Autotome FDA UDI
Identifiers
- Catalog Number
- AUTOTOME-MAN-HANDLE FDA UDI
- Primary DI / UDI-DI
- 00841336112186 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Manual non-rotary dental instrument handle 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual non-rotary dental instrument handle
Salvin Dental Specialties by Salvin Dental Specialties, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual non-rotary dental instrument handle.
- OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC. · Class I
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Medentika — Medentika GmbH · Class I
- DS Implants — Dentsply Implants Manufacturing GmbH · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- Implantium, Superline — Dentium Co., Ltd. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Salvin Dental Specialties, Llc
Sources (1)
- FDA UDI 9d5a0268-9ff1-488e-a0b9-f6f9d2d76550 34 fields · synced Jun 1, 2026