Identity
- Trade Name
- Cabinet Top Mount Rear Delivery FDA UDI
- Generic Name
- Dental delivery system instrument unit, pneumatic FDA UDI
- Device Name
- Under cabinet top mount 12 o'clock rear delivery FDA UDI
- Model / Reference
- P071438 FDA UDI
- Description
- Under cabinet top mount 12 o'clock rear delivery FDA UDI
Identifiers
- Catalog Number
- P071438 FDA UDI
- Primary DI / UDI-DI
- 00850043433002 FDA UDI
- 510(k) Number
- K983285 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system instrument unit, pneumatic 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
No
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
No
FDA UDI
Category: Dental delivery system instrument unit, pneumatic
Cabinet Top Mount Rear Delivery by Engle Dental Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K983285 also covers:
- 360 Asst Arm — Engle Dental Systems
- 360 Cuspidor Arm — Engle Dental Systems
- AS-1 Post Delivery System — Engle Dental Systems
- AS-1 Wall Delivery System — Engle Dental Systems
- AS-1 Wall Short Arm Delivery System — Engle Dental Systems
- AS1 360 Delivery System — Engle Dental Systems
- AS1 Dr./Asst Rear Delivery — Engle Dental Systems
- AS1 Wall Mnt Rear Delivery — Engle Dental Systems
- Assistant Wall Mount Arm — Engle Dental Systems
- Asst Arm - Long — Engle Dental Systems
- Asst Arm - Short — Engle Dental Systems
- Asst Arm - Top Mount — Engle Dental Systems
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Engle Dental Systems
Sources (1)
- FDA UDI 31037cb0-4889-4f10-881d-b6b544cfde0f 36 fields · synced Jun 8, 2026