Dental Burs
by Ningbo Sinyuan Bur & Tool Co., Ltd 50 variants
Ref FG 35, FGSS 6, FG SURG 330, FG SURG 331, FG SURG 35, FG 1, FG SURG 56, FG 10, FG 5, FGSS 36, FG 57L, FGSS 58, FG 555, FG SURG 6, FG SURG 7, FG 41, FG 40, FG 332L, FGSS 56, FG SURG 34, FG 333L, FG SURG 59, FGSS 37, FG 60, FG 1/2, FG 56, FG 36, FG 33 1/2, FG 61, FG 331, FGSS 5, FG 37L, FG SURG 1, FGSS 331, FGSS 8, FG SURG 3, FG SL 6, FG 6, FG 1/4, FG SURG 57L, FGSS 4, FGSS 35, FG SURG 57, FGSS 34, FG 56L, FG SL 4, FG 3, FG 2, FG 330, FG 957, FG 330L
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697636423BURS1PY | Date6 Jul 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- FG 35, FGSS 6, FG SURG 330, FG SURG 331, FG SURG 35, FG 1, FG SURG 56, FG 10, FG 5, FGSS 36, FG 57L, FGSS 58, FG 555, FG SURG 6, FG SURG 7, FG 41, FG 40, FG 332L, FGSS 56, FG SURG 34, FG 333L, FG SURG 59, FGSS 37, FG 60, FG 1/2, FG 56, FG 36, FG 33 1/2, FG 61, FG 331, FGSS 5, FG 37L, FG SURG 1, FGSS 331, FGSS 8, FG SURG 3, FG SL 6, FG 6, FG 1/4, FG SURG 57L, FGSS 4, FGSS 35, FG SURG 57, FGSS 34, FG 56L, FG SL 4, FG 3, FG 2, FG 330, FG 957, FG 330L
- Primary DI / UDI-DI
- 06976364230633, 06976364230084, 06976364230473, 06976364230480, 06976364230718, 06976364230138, 06976364230893, 06976364230220, 06976364230176, 06976364230596, 06976364230961, 06976364230756, 06976364231081, 06976364230305, 06976364230312, 06976364230695, 06976364230688, 06976364230541, 06976364230732, 06976364230701, 06976364230558, 06976364230923, 06976364230602, 06976364230831, 06976364230121, 06976364230794, 06976364230640, 06976364230619, 06976364230848, 06976364230442, 06976364230077, 06976364230763, 06976364230251, 06976364230404, 06976364230107, 06976364230275, 06976364230374, 06976364230183, 06976364230114, 06976364231005, 06976364230060, 06976364230589, 06976364230909, 06976364230572, 06976364230954, 06976364230350, 06976364230152, 06976364230145, 06976364230435, 06976364230879, 06976364230527
- Basic UDI-DI
- 697636423BURS1PY
- EMDN Code
- Q010501 Dental burs and abrasive disks, single-use
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000034089
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Ningbo Sinyuan Bur & Tool Co., Ltd
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No