Identity
- Trade Name
- Advance Dental Products FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- Advance Mail In Biological Indicators FDA UDI
- Model / Reference
- ADPST-12 FDA UDI
- Description
- Advance Mail In Biological Indicators FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00371347003147 FDA UDI
- 510(k) Number
- K023716 FDA UDI
- FDA Product Code
- FRC FDA UDI
- GMDN Term
- Biological sterilization indicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological sterilization indicator
A comprehensive medical device directory, featuring the Advance Dental Products device. Learn about its features, compliance, and FAQs.
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Cleared under the same submission
K023716 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Atlanta Dental Supply Company
Sources (1)
- FDA UDI ddfc9977-6d09-4fa9-b4ce-e3f36e26f7aa 34 fields · synced Jul 3, 2026