Identity
- Trade Name
- Lares Research FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- Motor driven dental contra angle handpiece with 1:5 gear ratio. FDA UDI
- Model / Reference
- Smoothdrive 1:5 Contra angle FDA UDI
- Description
- Motor driven dental contra angle handpiece with 1:5 gear ratio. FDA UDI
Identifiers
- Catalog Number
- 13502 FDA UDI
- Primary DI / UDI-DI
- D950135020 FDA UDI
- 510(k) Number
- K220874 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motorized handpiece/set, electric
Lares Research by Lares Research, 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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- S-9 LG surgical handpiece 1:1 — W & H Dentalwerk Bürmoos GmbH · Class II
- WG-57 LT — W & H Dentalwerk Bürmoos GmbH · Class I
- MAXSO — Beyes Dental Canada Inc · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Medidenta — Medidenta · Class I
- StarDental — DENTALEZ, INC. · Class I
- StarDental Instrument Solutions — DENTALEZ, INC. · Class I
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 4feac042-964b-4aab-99e1-70f72d35c2c7 36 fields · synced May 30, 2026