Identity
- Trade Name
- Reamer FDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- Dental Implant Instrument / Reamer FDA UDI
- Model / Reference
- DSD-RM28 FDA UDI
- Description
- Dental Implant Instrument / Reamer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169146298 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Steel dental bur, reusable 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Steel dental bur, reusable
Reamer by Dentis Co. , Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Steel dental bur, reusable.
- Tru-Fix — ACE SURGICAL SUPPLY CO., INC. · Class I
- KLOCKNER — SOADCO, S.L. · Class I
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
- House Brand Dentistry — Frontier Dental Supply Inc · Class I
- BUSCH®, BNA® — BUSCH & CO. GmbH & Co. KG · 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
- Dentis Co. , Ltd
Sources (1)
- FDA UDI 39d39b89-eb34-47e7-b171-9d39ab6e20bc 33 fields · synced Jun 8, 2026