Identity
- Trade Name
- IQ Dental FDA UDI
- Generic Name
- Dentine adhesive FDA UDI
- Device Name
- IQDENT ZAP UNIVERS. SELFETCH LC BOND 5ML FDA UDI
- Model / Reference
- FP-IQDENT-031 FDA UDI
- Description
- IQDENT ZAP UNIVERS. SELFETCH LC BOND 5ML FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816519020305 FDA UDI
- 510(k) Number
- K955328 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dentine adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dentine adhesive
IQ Dental by Iq Dental Supply Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K955328 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Iq Dental Supply Llc
Sources (1)
- FDA UDI acfbc725-ad68-4f15-8a31-fe9533a974c4 34 fields · synced Jun 1, 2026