Identity
- Trade Name
- Integrity FDA UDI
- Generic Name
- Dental precision attachment fitting/adjustment tool FDA UDI
- Device Name
- dental Attachement FDA UDI
- Model / Reference
- NTE-11 FDA UDI
- Description
- dental Attachement FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850012724162 FDA UDI
- 510(k) Number
- K070155 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental precision attachment fitting/adjustment tool FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental precision attachment fitting/adjustment tool
Integrity by Osseo Scientific, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070155 also covers:
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
- Integrity — OSSEO SCIENTIFIC, LLC
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
- Osseo Scientific, Llc
Sources (1)
- FDA UDI 186a405d-68cb-4a15-a868-0f4f0344d978 35 fields · synced Jun 1, 2026