Identity
- Trade Name
- FORENDO PASTE FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- CALCIUM HYDROXIDE WITH IODOFORM IN SILICON OIL BASE 2.2 gm syringe + 20 applicator tips FDA UDI
- Model / Reference
- FORE FDA UDI
- Description
- CALCIUM HYDROXIDE WITH IODOFORM IN SILICON OIL BASE 2.2 gm syringe + 20 applicator tips FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701FORE2 FDA UDI
- 510(k) Number
- K022734 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic filling/sealing material
Forendo Paste by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic filling/sealing material.
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- GIBSON — BENCO DENTAL SUPPLY CO. · Class II
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- DIA-ROOT BIO Sealer — DiaDent Group International · 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
- Pulpdent Corporation
Sources (1)
- FDA UDI 927fb34c-997a-4f34-bd23-5411ba2f9fcf 34 fields · synced Jun 9, 2026