FDA UDI
In Commercial Distribution
🇺🇸 United States
Glidewell™
DI: D745701120GLH00010
·
Model: 70-1120-GLH0001
·
Prismatik Dentalcraft, Inc
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Glidewell™
- Primary DI
- D745701120GLH00010
- Version / Model
- 70-1120-GLH0001
- Catalog Number
- 70-1120-GLH0001
- Company Name
- Prismatik Dentalcraft, Inc
- Labeler DUNS
- 022761689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-24
- Public Version
- 1
- Public Version Date
- 2025-12-02
- Public Version Status
- New
- Public Device Record Key
- 8c2afc56-31fd-4507-ad08-ed41c4c867df
Device Description
Glidewell™ Contra-angle Electric High-Speed Handpiece GL-45L
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGS | Handpiece, contra- and right-angle attachment, dental | Dental | 872.4200 | 1 |
| EBW | Controller, foot, handpiece and cord | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60930 | Dental delivery system instrument unit, electric | A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D745701120GLH00010 | HIBCC |