Identity
- Trade Name
- DentaSonic FDA UDI
- Generic Name
- Margin finishing dental file/rasp, reusable FDA UDI
- Device Name
- DS DIASTRIP REFILL 2-SIDE 60 MM PK12 FDA UDI
- Model / Reference
- 55-FDM0-1260 FDA UDI
- Description
- DS DIASTRIP REFILL 2-SIDE 60 MM PK12 FDA UDI
Identifiers
- Catalog Number
- 55-FDM0-1260 FDA UDI
- Primary DI / UDI-DI
- D78855FDM012601 FDA UDI
- FDA Product Code
- EMI FDA UDI
- GMDN Term
- Margin finishing dental file/rasp, 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
Yes
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
No
FDA UDI
Category: Margin finishing dental file/rasp, reusable
DentaSonic by GC Orthodontics America Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Margin finishing dental file/rasp, reusable.
- BLUE AND GREEN — NORDENT MANUFACTURING INC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- HU-FRIEDY — HU-FRIEDY MFG CO., LLC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · 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
- GC Orthodontics America Inc.
Sources (1)
- FDA UDI 3d120ad4-3c70-44ca-b893-e2519b737744 35 fields · synced Jun 1, 2026