Identity
- Trade Name
- Scott's Select MaxCUT FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Device Name
- MaXcut Standard Highspeed Dental Handpiece: 4 hole standard backend, tool type chuck, single port spray, 350,000 - 400,000 rpm, autoclavable and chemiclavable safe. https://www.scottsdental.com/maxcut-standard-highspeed.html?queryID=e598f9c8c610838b9f0afdc1f69504ad&objectID=24124&indexName=magento2_production_default_products FDA UDI
- Model / Reference
- 135-1316 FDA UDI
- Description
- MaXcut Standard Highspeed Dental Handpiece: 4 hole standard backend, tool type chuck, single port spray, 350,000 - 400,000 rpm, autoclavable and chemiclavable safe. https://www.scottsdental.com/maxcut-standard-highspeed.html?queryID=e598f9c8c610838b9f0afdc1f69504ad&objectID=24124&indexName=magento2_production_default_products FDA UDI
Identifiers
- Catalog Number
- 135-1316 FDA UDI
- Primary DI / UDI-DI
- D77813513160 FDA UDI
- 510(k) Number
- K093084 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental surgical power tool motorized handpiece/set, pneumatic 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
No
FDA UDI
Category: Dental surgical power tool motorized handpiece/set, pneumatic
Scott's Select MaxCUT by Scott's Dental Supply L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K093084 also covers:
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
- Scott's Dental Supply L.l.c.
Sources (1)
- FDA UDI abf66384-2b9a-428d-9fdc-2cdb5a746753 36 fields · synced May 30, 2026