Skip to content

Salvin Dental Specialties INDIV-LV-493B

by Salvin Dental Specialties, LLC GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841336100374 UDI-DIDate28 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1872-2017 FDA Class II initiated 2 Feb 2017

    The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.

Specification

GUDID

Trade Name
Salvin Dental Specialties
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Model / Ref / Catalog
INDIV-LV-493B
Primary DI / UDI-DI
00841336100374
510(k) Number
FDA Product Code
GAM
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device Class
Class II
Regulation Number
878.4493
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K072229)

Show all (12)

Other devices from Salvin Dental Specialties, LLC

See all devices from Salvin Dental Specialties, LLC →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No