Identity
- Trade Name
- Midmark FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- Midmark Procenter Console Mounted Assistant's Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures. FDA UDI
- Model / Reference
- 153604CE FDA UDI
- Description
- Midmark Procenter Console Mounted Assistant's Unit Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures. FDA UDI
Identifiers
- Catalog Number
- 153604CE FDA UDI
- Primary DI / UDI-DI
- 00841709110344 FDA UDI
- 510(k) Number
- K003090 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
K003090 also covers:
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
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 e823b833-6e65-4b9a-94c3-4ac8e73901d6 37 fields · synced Jun 8, 2026