510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922673Substantially Equivalent

Flexible Ceramic Ropes and Tapes for Bonding

Glasspan, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922673 is the FDA 510(k) clearance record for FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING, a class II device, cleared for Glasspan, Inc. on under FDA product code ELS (Splint, Endodontic Stabilizing). FDA records list one 510(k) clearance for Glasspan, Inc. As of , FDA records show no recalls naming K922673.

Clearance record

Decision date
Received
(631 days to decision)
Product code
ELS Splint, Endodontic Stabilizing
Regulation
21 CFR 872.3890
Device class
Class II
Review panel
Dental
Applicant
Glasspan, Inc. 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code ELS

Trailing 12 months

FDA records hold no clearances under product code ELS in the trailing twelve months.

FDA records show no clearances under product code ELS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260