Identity
- Trade Name
- Pastel FDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- Prophy angle, disposable, soft cup, 100 box FDA UDI
- Model / Reference
- Prophy angle FDA UDI
- Description
- Prophy angle, disposable, soft cup, 100 box FDA UDI
Identifiers
- Catalog Number
- 11646 FDA UDI
- Primary DI / UDI-DI
- D950116461 FDA UDI
- 510(k) Number
- K973062 FDA UDI
- FDA Product Code
- EFA FDA UDI
- GMDN Term
- Dental material application tool, single-use 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material application tool, single-use
Pastel by Lares Research, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K973062 also covers:
- Sparkle Prophy Angle — CROSSTEX INTERNATIONAL, INC.
- Sparkle™ EZ Contra Angle — CROSSTEX INTERNATIONAL, INC.
- Sparkle™ EZ Contra Angle — CROSSTEX INTERNATIONAL, INC.
- Sparkle™ Prophy Angle — CROSSTEX INTERNATIONAL, INC.
- Sparkle™ Prophy Angle — CROSSTEX INTERNATIONAL, INC.
- Sparkle™ Prophy Angle — CROSSTEX INTERNATIONAL, INC.
- Sparkle™ Prophy Angle — CROSSTEX INTERNATIONAL, INC.
- Twist Prophy Angles Disposable Cup — CROSSTEX INTERNATIONAL, INC.
- Twist plus Oscillating Prophy Angle — CROSSTEX INTERNATIONAL, INC.
- Twist plus Oscillating Prophy Angle — CROSSTEX INTERNATIONAL, INC.
- Twist plus Oscillating Prophy Angle — CROSSTEX INTERNATIONAL, INC.
- Twist™ Disposable Prophy Angles — CROSSTEX INTERNATIONAL, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Lares Research, Inc.
Sources (1)
- FDA UDI 3cd4b27c-576b-4fa9-b140-b22bdcb2eb49 36 fields · synced May 30, 2026