GATES GLIDDEN DRILLS— 510(k) K905418

Substantially Equivalent

The Hygenic Corp.

FDA 510(k) clearance K905418 for GATES GLIDDEN DRILLS, Substantially Equivalent on 1991-07-25. Applicant: The Hygenic Corp.. Device class: 1.

Clearance details

Applicant: The Hygenic Corp.
Product code: Code DZA
Device class: Class 1
Regulation: 21 CFR 872.4130
Advisory panel: Dental
Date received: 1990-12-04
Decision date: 1991-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZA

K984508 — SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD1999-06-25
K962979 — S-53 INTRORAL DENTAL SYSTEM1996-09-25
K954790 — PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS1996-01-16
K914724 — ADA SHANK EXTENSION1993-07-27
K901097 — FILLOCK REAMER1990-04-25

More clearances from The Hygenic Corp.

K954990 — DENTAL DAM1996-01-26
K930764 — ENDO-ICE-PULP TESTER-THERMAL1993-05-27
K911225 — TRAY DOUGH1991-04-17
K905640 — SOLID CORE GUTTA PERCHA CARRIER1991-03-05
K900301 — NOVUS BONDING AGENT1990-05-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.