Identity
- Trade Name
- DCI Edge FDA UDI
- Generic Name
- Dental delivery system instrument unit, pneumatic FDA UDI
- Device Name
- Series 5 Plus Over the Patient Auto Dental Unit w/Large PMU and PMU Assistant Mount FDA UDI
- Model / Reference
- DO5756+ FDA UDI
- Description
- Series 5 Plus Over the Patient Auto Dental Unit w/Large PMU and PMU Assistant Mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810021437156 FDA UDI
- 510(k) Number
- K250473 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
DCI Edge by DCI International, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
Cleared under the same submission
K250473 also covers:
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
- DCI Edge — DCI International, LLC
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
- DCI International, LLC
Sources (1)
- FDA UDI bc32f33e-40a0-46be-82c0-17199eb86581 35 fields · synced Jun 9, 2026