FDA UDI
In Commercial Distribution
🇺🇸 United States
Scott's Select MaxCUT
DI: D77813513160
·
Model: 135-1316
·
SCOTT'S DENTAL SUPPLY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Scott's Select MaxCUT
- Primary DI
- D77813513160
- Version / Model
- 135-1316
- Catalog Number
- 135-1316
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-29
- Public Version
- 1
- Public Version Date
- 2024-04-08
- Public Version Status
- New
- Public Device Record Key
- abf66384-2b9a-428d-9fdc-2cdb5a746753
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66244 | Dental surgical power tool motorized handpiece/set, pneumatic | A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes a pneumatic motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D77813513160 | HIBCC |
Customer Contacts
- Phone
- (800) 901-3368
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093084 | 000 |