← Back to catalogue
FG Swiss Goldie fine
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 314CSG368.023Model FG Swiss Goldie superfine
by Diaswiss SA
Identity
- Trade Name
- Swiss Goldie EUDAMEDFG Swiss Goldie fine FDA UDIFG Swiss Goldie superfine FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- Dental Diamond Rotary Instrument EUDAMEDDental diamond instrument for intraoral use FDA UDI
- Model / Reference
- 314CSG368.023 EUDAMEDFDA UDIFG Swiss Goldie superfine EUDAMED314FSG879.012 FDA UDI
- Description
- Dental diamond instrument for intraoral use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630049979895 EUDAMEDFDA UDI07630049979017 FDA UDI
- Basic UDI-DI
- B-07630049979895 EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4535 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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: Diamond dental bur, reusable
FG Swiss Goldie fine by Diaswiss SA — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| 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
- Diaswiss SA
Sources (3)
- FDA UDI 398a80e4-8b2b-4a43-8483-62c090fc3eb7 33 fields · synced Aug 1, 2026
- FDA UDI 425c7576-9960-4e2e-83c3-0a8c7af4a560 33 fields · synced May 30, 2026
- EUDAMED b6e7166e-024f-4aee-b4c2-210cef326371 61 fields · synced Aug 1, 2026