Identity
- Trade Name
- EDTA 18% EUDAMEDEDTA FDA UDI
- Generic Name
- Endodontic reaming aid material FDA UDI
- Device Name
- EDTA 18% Solution EUDAMEDEDTA 18% Solution IndiSpense Refill FDA UDI
- Model / Reference
- 162 EUDAMEDFDA UDI
- Description
- EDTA 18% Solution IndiSpense Refill FDA UDI
Identifiers
- Catalog Number
- 162 FDA UDI
- Primary DI / UDI-DI
- 00883205105431 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF002AF EUDAMED
- 510(k) Number
- K934415 FDA UDI
- FDA Product Code
- KJJ FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic reaming aid material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic reaming aid material
Edta by Ultradent Products, Inc. — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic reaming aid material.
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- EDTA SOLUTION, 17% — Pulpdent Corporation · Class I
- PREP-RITE™ RC — Pulpdent Corporation
- RC-Prep — PREMIER DENTAL PRODUCTS COMPANY · Class I
Cleared under the same submission
K934415 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (2)
- FDA UDI e07b8a78-c1cd-4888-b5eb-fc1dbcdb49b7 37 fields · synced Jul 11, 2026
- EUDAMED be4eefba-83bc-48d6-9943-5353fc23b246 61 fields · synced Jul 11, 2026