Identity
- Trade Name
- StarDental Instrument Solutions FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- 1:1 ST ATTACHMENT, ETORQUE FDA UDI
- Model / Reference
- 265473 FDA UDI
- Description
- 1:1 ST ATTACHMENT, ETORQUE FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7022654730 FDA UDI
- 510(k) Number
- K132356 FDA UDI
- FDA Product Code
- EGS 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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional 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
Similar devices
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
- X55L — NAKANISHI INC. · Class I
- 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 c23ccc4e-5c5d-456b-b606-6ccc68ccaf3f 35 fields · synced May 30, 2026