Identity
- Trade Name
- Sparkle™ EZ Contra Angle FDA UDI
- Generic Name
- Dental polishing cup, single-use FDA UDI
- Device Name
- Prophy Angle, Firm Cup, White FDA UDI
- Model / Reference
- TPAFEZ FDA UDI
- Description
- Prophy Angle, Firm Cup, White FDA UDI
Identifiers
- Catalog Number
- TPAFEZ FDA UDI
- Primary DI / UDI-DI
- 10732224000371 FDA UDI
- FDA Product Code
- EGS FDA UDI
- GMDN Term
- Dental polishing cup, 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental polishing cup, single-use
Sparkle™ EZ Contra Angle by Crosstex International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental polishing cup, single-use.
- Premium Plus — Premium Plus International Limited · Class I
- ProFlare — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Premium Plus — Premium Plus International Limited · Class I
- ONEGLOSS — SHOFU DENTAL CORP. · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Premium Plus — Premium Plus International Limited · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Premium Plus — Premium Plus International Limited · Class I
Cleared under the same submission
K030603 also covers:
- MEDICOM DENTICARE — AMD Medicom Inc
- MEDICOM DENTICARE SWIVEL DPA, FIRM CUP — AMD Medicom Inc
- MEDICOM DENTICARE SWIVEL DPA, SOFT CUP — AMD Medicom Inc
- MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSH — AMD Medicom Inc
- Sparkle Prophy 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 plus Oscillating Prophy Angle — CROSSTEX INTERNATIONAL, INC.
- Twist plus Oscillating Prophy Angle — CROSSTEX INTERNATIONAL, INC.
K973062 also covers:
- Sparkle Prophy 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.
- Twist™ Disposable Prophy Angles Brush — 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
- Crosstex International, Inc.
Sources (1)
- FDA UDI 91139de1-2489-44ac-8d51-6d086bf07472 36 fields · synced Jun 8, 2026