Identity
- Trade Name
- PREP-RITE™ RC FDA UDI
- Generic Name
- Endodontic reaming aid material FDA UDI
- Device Name
- Kit: 4 x 5 gm syringes -Viscous EDTA Gel for picking up on files FDA UDI
- Model / Reference
- PRC FDA UDI
- Description
- Kit: 4 x 5 gm syringes -Viscous EDTA Gel for picking up on files FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701PRC2 FDA UDI
- GMDN Term
- Endodontic reaming aid material FDA UDI
Classification
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic reaming aid material
Prep-Rite™ Rc by Pulpdent Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic reaming aid material.
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- Sonendo 17% EDTA — SONENDO, INC. · Class I
- ChlorCid V — ULTRADENT PRODUCTS, INC. · U
- RC-Prep — PREMIER DENTAL PRODUCTS COMPANY · Class I
- RC-Prep — PREMIER DENTAL PRODUCTS COMPANY · Class I
- ChlorCid — ULTRADENT PRODUCTS, INC. · U
- RC-Prep — PREMIER DENTAL PRODUCTS COMPANY · Class I
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA UDI b2697c86-f38b-4eac-bd9c-1fcb42cbfd55 33 fields · synced Jun 9, 2026