Identity
- Trade Name
- Midmark FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- Midmark 4 Position Elevance Console Mounted Traditional Instrument Delivery Systems are intended to provide dental professionals with air, water, and suction along with low-voltage electricity to operate dental handpieces, syringes, and accessories during dental examinations and treatments. FDA UDI
- Model / Reference
- 153800-013 FDA UDI
- Description
- Midmark 4 Position Elevance Console Mounted Traditional Instrument Delivery Systems are intended to provide dental professionals with air, water, and suction along with low-voltage electricity to operate dental handpieces, syringes, and accessories during dental examinations and treatments. FDA UDI
Identifiers
- Catalog Number
- 153800-013 FDA UDI
- Primary DI / UDI-DI
- 00841709109744 FDA UDI
- 510(k) Number
- K120239 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system instrument unit, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
Category: Dental delivery system instrument unit, electric
Midmark by Midmark Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120239 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
- Midmark Corporation
Sources (1)
- FDA UDI 4acdc20e-43f5-46be-bff8-3948d25b980d 37 fields · synced Jun 8, 2026