Device Atlas

Sylvan Dental Headlight System

Q: What is the product code of K923949?

The FDA product code is EBA – Light, Surgical Headlight, a Class I (low risk) device regulated under 21 CFR 872.4630.

FDA 510(k) K923949 · Sylvan Medical Fiberoptics

Substantially Equivalent

510(k) numberK923949

Submission

Device name: Sylvan Dental Headlight System
Applicant: Sylvan Medical Fiberoptics
North Huntingdon, PA, US
Received: August 5, 1992
Decision date: October 16, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: EBA – Light, Surgical Headlight
Device class: Class I (low risk)
Regulation: 21 CFR 872.4630
Specialty: Dental

Other 510(k)s with product code EBA

510(k)	Device	Applicant	Decision
K070287	PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500EBA · Traditional	Photonic Optische Gerate GmbH & Cokg	02/12/2007SE
K893458	Fiberoptic Headlight SystemEBA · Traditional	Cuda Products Co.	06/22/1989SE
K854646	Vega Dental Operating LightEBA · Traditional	Alpine Dental Equipment Co.	03/06/1986SE
K842515	Surgical HeadlightEBA · Traditional	Good-Lite Co.	08/02/1984SE
K842358	IsolightEBA · Traditional	Planmeca USA, Inc.	07/31/1984SE
K822265	Fiberoptic Light Source W/Related ItemsEBA · Traditional	Kelleher Corp.	09/28/1982SE
K810117	Halogen Headlight SystemEBA · Traditional	Colmed, Ltd.	02/10/1981SE
K790807	MetalitEBA · Traditional	Harry J. Bosworth Co.	08/03/1979SE
K790806	PorcelitEBA · Traditional	Harry J. Bosworth Co.	08/03/1979SE

Questions and answers

When was Sylvan Dental Headlight System cleared by the FDA?

Sylvan Dental Headlight System (K923949) received a 510(k) decision of Substantially Equivalent on October 16, 1992, 72 days after the submission was received.

What is the product code of K923949?

The FDA product code is EBA – Light, Surgical Headlight, a Class I (low risk) device regulated under 21 CFR 872.4630.