FDA UDI
In Commercial Distribution
🇺🇸 United States
MK-dent
DI: E490AM00021
·
Model: ACCESSORIES
·
MK-Dent GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MK-dent
- Primary DI
- E490AM00021
- Version / Model
- ACCESSORIES
- Catalog Number
- AM0002
- Company Name
- MK-Dent GmbH
- Labeler DUNS
- 343618943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-14
- Public Version
- 1
- Public Version Date
- 2024-10-22
- Public Version Status
- New
- Public Device Record Key
- 84be1aa7-c328-443e-96e9-1a64c9e37015
Device Description
Air Motor
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66228 | Dental surgical power tool motor, pneumatic | A hand-held, pneumatically-powered component of a surgical power tool assembly designed to convert the energy from a compressed gas source [e.g., surgical-grade air or nitrogen (N2)] into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E490AM00021 | HIBCC | ||||
| Previous | 04050546000015 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051872 | 000 |