Identity
- Trade Name
- Quala FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- Quala A1 Temporary C & B 10:1 Cartridge FDA UDI
- Model / Reference
- Q85801 FDA UDI
- Description
- Quala A1 Temporary C & B 10:1 Cartridge FDA UDI
Identifiers
- Catalog Number
- Q85801 FDA UDI
- Primary DI / UDI-DI
- D023Q858011 FDA UDI
- 510(k) Number
- K102753 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Silicone dental impression materialUltrasonic dental scaling/debridement system handpiece tip, periodontal
Quala by National Distribution & Contracting, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102753 also covers:
- MIMIC-3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Defend — YOUNG MYDENT, LLC
- Defend — YOUNG MYDENT, LLC
- Defend — YOUNG MYDENT, LLC
- Defend — YOUNG MYDENT, LLC
- Defend — YOUNG MYDENT, LLC
- Defend — Young Innovations, Inc.
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
- National Distribution & Contracting, Inc.
Sources (1)
- FDA UDI 374335f3-aa26-481e-8b50-c89e717dc47f 36 fields · synced Jun 7, 2026