Identity
- Trade Name
- DCI Edge FDA UDI
- Generic Name
- Dental delivery system instrument unit, pneumatic FDA UDI
- Device Name
- Rear Mount Assistant's Pkg. FDA UDI
- Model / Reference
- RM5 FDA UDI
- Description
- Rear Mount Assistant's Pkg. FDA UDI
Identifiers
- Catalog Number
- RM5152 FDA UDI
- Primary DI / UDI-DI
- 00810021439242 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental delivery system instrument unit, pneumatic
Dental delivery system instrument unit, pneumatic. Designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. Features include a platform for displaying powered dental instruments, control panels for setting operating parameters, and portability options.
Similar devices
Also classified as Dental delivery system instrument unit, pneumatic.
- AS1 Wall Mnt Rear Delivery — Engle Dental Systems · Class I
- E300 Dr./Asst Rear Delivery — Engle Dental Systems · Class I
- Asst Silver Cart — Engle Dental Systems · Class I
- ultrapro Tx air — ULTRADENT PRODUCTS, INC. · Class I
- Asst Tabletop Cart — Engle Dental Systems · Class I
- Biotec — Biotec Incorporated · Class I
- Rear Delivery — Engle Dental Systems · Class I
- AC-1.0 Advanced Air — W & H Dentalwerk Bürmoos GmbH · Class I
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
- DCI International, LLC
Sources (1)
- FDA UDI d4a064dd-8021-4460-beec-cb2761d81441 35 fields · synced Jun 27, 2026