Identity
- Trade Name
- Integrated Endo System FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Model / Reference
- Meet Endo-II FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970873260389 FDA UDI
- 510(k) Number
- K242317 FDA UDI
- FDA Product Code
- EKR FDA UDILQY FDA UDIEKX FDA UDIELC FDA UDI
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI872.4200 FDA UDI872.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Ultrasonic dental scaling/debridement systemDental surgical power tool motor, electricEndodontic obturation systemAnaerobic chamber
Integrated Endo System by Denjoy Dental Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Denjoy Dental Co., Ltd
Sources (1)
- FDA UDI eb99b5e7-8b28-4da2-a4bd-d1b01fb7a322 33 fields · synced Jun 8, 2026