Identity
- Trade Name
- Elements FDA UDI
- Generic Name
- Dental pulp analysis system FDA UDI
- Device Name
- ELEMENTS DIAGNOSTIC UNIT FDA UDI
- Model / Reference
- 973-0300 FDA UDI
- Description
- ELEMENTS DIAGNOSTIC UNIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989061871 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
Yes
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 pulp analysis system
Elements by Ormco Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental pulp analysis system.
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- Digitest™ — PARKELL, INC. · Class II
- Gentle Pulse™ — PARKELL, INC. · Class II
- PULP TESTER — DENJOY DENTAL CO., LTD · Class II
- Vitality Scanner — KERR 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
- Ormco Corporation
Sources (1)
- FDA UDI 34289f2d-078f-4182-894c-415ba28f9b54 35 fields · synced Jun 9, 2026