Identity
- Trade Name
- MEDICOM DENTICARE FDA UDI
- Generic Name
- Dental polishing cup, single-use FDA UDI
- Device Name
- MEDICOM DENTICARE SWIVEL DPA, Sample Pack FDA UDI
- Model / Reference
- Swivel-SP3 FDA UDI
- Description
- MEDICOM DENTICARE SWIVEL DPA, Sample Pack FDA UDI
Identifiers
- Catalog Number
- Swivel-SP3 FDA UDI
- Primary DI / UDI-DI
- 10686864061141 FDA UDI
- 510(k) Number
- K030603 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental polishing cup, single-use
Medicom Denticare by AMD Medicom Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K030603 also covers:
- 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™ 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.
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
- AMD Medicom Inc
Sources (1)
- FDA UDI 35864f29-93da-4435-969a-17c257bb6a0c 36 fields · synced May 30, 2026