Identity
- Trade Name
- Root Canal Instruments Kit FDA UDI
- Generic Name
- Dental examination kit FDA UDI
- Model / Reference
- DY21-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970873260297 FDA UDI
- FDA Product Code
- NYC FDA UDI
- GMDN Term
- Dental examination kit 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
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
Category: Dental examination kit
Root Canal Instruments Kit by Denjoy Dental Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental examination kit.
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Centurion — Centurion Medical Products · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · 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
- Denjoy Dental Co., Ltd
Sources (1)
- FDA UDI 89a46a59-6224-4156-b44d-870ae53a0cca 32 fields · synced Jun 8, 2026