Identity
- Trade Name
- Slim Line FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Chisel, Osteotome, Surgical FDA UDI
- Model / Reference
- XRB3535 FDA UDI
- Description
- Chisel, Osteotome, Surgical FDA UDI
Identifiers
- Catalog Number
- XRB3535 FDA UDI
- Primary DI / UDI-DI
- 08809544905596 FDA UDI
- FDA Product Code
- EMM FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, 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
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
- Outer Diameter — 3.5 Millimeter FDA UDILength — 3.5 Millimeter FDA UDI
Category: Fixture/appliance dental drill bit, reusable
Slim Line by Dentium Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Bone Compaction Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Prima Plus — Keystone Dental Inc. · Class I
- FTN Tapered Drill — DIO Corporation · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant 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
- Dentium Co., Ltd.
Sources (1)
- FDA UDI 34d9e013-5eab-4c97-aaf2-2e5ceb54a134 36 fields · synced May 30, 2026