Identity
- Trade Name
- A-dec FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- A-dec CART343pro Cart Delivery System FDA UDI
- Model / Reference
- 343pro FDA UDI
- Description
- A-dec CART343pro Cart Delivery System FDA UDI
Identifiers
- Catalog Number
- 343pro FDA UDI
- Primary DI / UDI-DI
- 10194665007300 FDA UDI
- 510(k) Number
- K213932 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
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
Yes
FDA UDI
Category: Dental delivery system instrument unit, electric
A-dec by A-Dec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DCI Edge — DCI International, LLC · Class I
- SCALEX — Dentamerica · Class II
- Standard Triton Self-Contained Delivery Systems — ASI MEDICAL, INC. · Class I
- Dentacenter Operative Dental Unit — Safari Dentaire Inc · Class I
Cleared under the same submission
K213932 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
- A-Dec, Inc.
Sources (1)
- FDA UDI 45217e16-c1b3-44dc-81d2-139e05e1fc9a 35 fields · synced May 30, 2026