Identity
- Trade Name
- Astek FDA UDI
- Generic Name
- Dental delivery system irrigation handpiece FDA UDI
- Device Name
- O Ring Kit Standard FDA UDI
- Model / Reference
- 116239ASTEK FDA UDI
- Description
- O Ring Kit Standard FDA UDI
Identifiers
- Catalog Number
- 116239ASTEK FDA UDI
- Primary DI / UDI-DI
- 00840326422106 FDA UDI
- FDA Product Code
- ECB FDA UDI
- GMDN Term
- Dental delivery system irrigation handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Astek by Young Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Young Innovations, Inc.
Sources (1)
- FDA UDI e87b897d-76db-4a7b-8b3f-e1d490d9d130 36 fields · synced Jun 8, 2026