Identity
- Trade Name
- FG Swiss Goldie standard FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- Dental diamond instrument for intraoral use FDA UDI
- Model / Reference
- 314SSG909.037 FDA UDI
- Description
- Dental diamond instrument for intraoral use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630049980310 FDA UDI
- FDA Product Code
- DZP FDA UDI
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4535 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Diamond dental bur, reusable
The FG Swiss Goldie standard dental diamond instrument is a high-performance, reusable cutting device designed for intraoral use. Featuring advanced materials and precise cutting technology, it provides accurate cuts in hard structures such as teeth and bone. With its ergonomic design and easy maneuverability, this instrument is ideal for professionals seeking to enhance their dental procedures.
Similar devices
Also classified as Diamond dental bur, reusable.
- Midwest Diamonds — Sirona Dental Systems GmbH · Class I
- Sabur by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- MAXCUT DIAMOND BURS (6/pk) CRS 6852-012 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- Diatech Diamond Instruments — Coltène/Whaledent AG · Class I
- HORICO — Hopf, Ringleb & Co. GmbH & Cie. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Diaswiss SA
Sources (1)
- FDA UDI c33d1e38-cc03-49c6-855f-2dcb83fbb4ec 33 fields · synced Jul 26, 2026