Identity
- Trade Name
- Implantium, Superline FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Accessories, Implant, Dental, Endosseous FDA UDI
- Model / Reference
- SDA17R FDA UDI
- Description
- Accessories, Implant, Dental, Endosseous FDA UDI
Identifiers
- Catalog Number
- SDA17R FDA UDI
- Primary DI / UDI-DI
- 08809162703871 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Manual non-rotary dental instrument handle 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 17 Millimeter FDA UDI
Category: Manual non-rotary dental instrument handle
Implantium, Superline by Dentium Co., Ltd. — 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
- Medentika — Medentika GmbH · Class I
- DS Implants — Dentsply Implants Manufacturing GmbH · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- Bioclear Instrument — Bioclear Matrix Systems, LLC · 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
- Dentium Co., Ltd.
Sources (1)
- FDA UDI 2a73c4ac-dced-4b14-9a0c-5a0ad382f9bc 36 fields · synced Jun 8, 2026