Identity
- Trade Name
- StarDental Instrument Solutions FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- ISTAR CORDLESS PROPHY MOTOR (REPLACEMENT) FDA UDI
- Model / Reference
- 265992 FDA UDI
- Description
- ISTAR CORDLESS PROPHY MOTOR (REPLACEMENT) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7022659920 FDA UDI
- 510(k) Number
- K131578 FDA UDI
- FDA Product Code
- EKX FDA UDI
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental surgical power tool motorized handpiece/set, electric
StarDental Instrument Solutions by Dentalez, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental surgical power tool motorized handpiece/set, electric.
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- MAXSO — Beyes Dental Canada Inc · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Medidenta — Medidenta · Class I
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- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
Cleared under the same submission
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
- Dentalez, Inc.
Sources (1)
- FDA UDI fe7735ef-5f50-4994-a0d7-36f342e68931 35 fields · synced Jun 6, 2026