510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923949Substantially Equivalent

Sylvan Dental Headlight System

Sylvan Medical Fiberoptics, North Huntingdon PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923949 is the FDA 510(k) clearance record for SYLVAN DENTAL HEADLIGHT SYSTEM, a class I device, cleared for Sylvan Medical Fiberoptics on under FDA product code EBA (Light, Surgical Headlight). FDA records list one 510(k) clearance for Sylvan Medical Fiberoptics. As of , FDA records show no recalls naming K923949.

Clearance record

Decision date
Received
(72 days to decision)
Product code
EBA Light, Surgical Headlight
Regulation
21 CFR 872.4630
Device class
Class I
Review panel
Dental
Applicant
Sylvan Medical Fiberoptics 1061 Main St., North Huntingdon PA
510(k) summary
Statement
Third party review
No

Clearances, product code EBA

Trailing 12 months

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

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