Identity
- Trade Name
- Sure-endo FDA UDI
- Generic Name
- Gingival retraction cord, medicated FDA UDI
- Device Name
- Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #000.0, 100 in (254cm) FDA UDI
- Model / Reference
- SCP-000.0 FDA UDI
- Description
- Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #000.0, 100 in (254cm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809264299883 FDA UDI
- 510(k) Number
- K132526 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction cord, medicated FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
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: Gingival retraction cord, medicated
Sure-endo by Sure Dent Corporation — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, medicated.
- Racord Retraction Cord 07/00 — PASCAL COMPANY, INC. · U
- Racellet 2 Pellets — PASCAL COMPANY, INC. · U
- SilTrax Plus Retraction Cord 7/00 — PASCAL COMPANY, INC. · U
- Expasyl — KERR CORPORATION · U
- SilTrax EPI Retraction Cord 9/1 — PASCAL COMPANY, INC. · U
- Expasyl — KERR CORPORATION · U
- Re-Cord™ Knitted Retraction Cord #3 — Den-Mat Holdings, LLC · Class I
- Racellet 3 Pellets — PASCAL COMPANY, INC. · U
Cleared under the same submission
K132526 also covers:
- Knit-Pak+ — PREMIER DENTAL PRODUCTS COMPANY
- Knit-Pak+ — PREMIER DENTAL PRODUCTS COMPANY
- Knit-Pak+ — PREMIER DENTAL PRODUCTS COMPANY
- Knit-Pak+ — PREMIER DENTAL PRODUCTS COMPANY
- Knit-Pak+ — PREMIER DENTAL PRODUCTS COMPANY
- Knit-Pak+ — PREMIER DENTAL PRODUCTS COMPANY
- Knit-Pak+ — PREMIER DENTAL PRODUCTS COMPANY
- Sure-endo — SURE DENT CORPORATION
- Sure-endo — SURE DENT CORPORATION
- Sure-endo — SURE DENT CORPORATION
- Sure-endo — SURE DENT CORPORATION
- Sure-endo — SURE DENT CORPORATION
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 U | Pending data |
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Manufacturer
- Manufacturer
- Sure Dent Corporation
Sources (1)
- FDA UDI 341ab430-3b6f-45ef-b5c3-e2533d741da4 35 fields · synced May 30, 2026