SPECULITE/ORALLITE— 510(k) K003995

Substantially Equivalent

Trylon Corp.

FDA 510(k) clearance K003995 for SPECULITE/ORALLITE, Substantially Equivalent on 2001-03-16. Applicant: Trylon Corp.. Device class: 1.

Clearance details

Applicant
Trylon Corp.
Product code
Code EAZ
Device class
Class 1
Regulation
21 CFR 872.4630
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Torrance, CA, US
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