Identity
- Trade Name
- Elements FDA UDI
- Generic Name
- Dental pulp analysis system FDA UDI
- Device Name
- AC Adaptor FDA UDI
- Model / Reference
- 973-0302 FDA UDI
- Description
- AC Adaptor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195062031045 FDA UDI
- FDA Product Code
- EAT FDA UDI
- GMDN Term
- Dental pulp analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1720 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental pulp analysis system
Elements by Kerr Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental pulp analysis system.
- Elements — Ormco Corporation · Class II
- Gentle Pulse™ — PARKELL, INC. · Class II
- MINI-TIP KIT — Ormco Corporation · Class II
- Digitest™ — PARKELL, INC. · Class II
- Gentle Pulse™ — PARKELL, INC. · Class II
- PULP TESTER — DENJOY DENTAL CO., LTD · Class II
- Digitest™ — PARKELL, INC. · Class II
- GROUNDING LEAD WITH LIP CLIP — Ormco Corporation · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Kerr Corporation
Sources (1)
- FDA UDI 93028bb4-273b-4928-bf53-7aca38e230a1 34 fields · synced Jun 8, 2026