510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863758Substantially Equivalent

Ortho-Bite Wax Wafer

Columbus Dental Mfg. Co., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863758 is the FDA 510(k) clearance record for ORTHO-BITE WAX WAFER, a class I device, cleared for Columbus Dental Mfg. Co. on under FDA product code EGD (Wax, Dental, Intraoral). FDA records list 11 510(k) clearances for Columbus Dental Mfg. Co., from to . As of , FDA records show no recalls naming K863758.

Clearance record

Decision date
Received
(12 days to decision)
Product code
EGD Wax, Dental, Intraoral
Regulation
21 CFR 872.6890
Device class
Class I
Review panel
Dental
Applicant
Columbus Dental Mfg. Co. 1000 Chouteau Ave., St. Louis MO
Third party review
No

Clearances, product code EGD

Trailing 12 months

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

FDA records show no clearances under product code EGD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EGD, 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