Cleared Traditional

S-53 INTRORAL DENTAL SYSTEM

K962979 · Del Medical Systems Corp. · Dental
Sep 1996
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K962979 is an FDA 510(k) clearance for the S-53 INTRORAL DENTAL SYSTEM, a Drill, Dental, Intraoral (Class I — General Controls, product code DZA), submitted by Del Medical Systems Corp. (Valhalla, US). The FDA issued a Cleared decision on September 25, 1996, 56 days after receiving the submission on July 31, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.4130.

Submission Details

510(k) Number K962979 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1996
Decision Date September 25, 1996
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZA — Drill, Dental, Intraoral
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4130

Similar Devices — DZA Drill, Dental, Intraoral

All 12
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
K984508 · W&H Dentalwerk Buermoos GmbH · Jun 1999
PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
K954790 · Tulsa Dental Products, Ltd. · Jan 1996
ADA SHANK EXTENSION
K914724 · Implant Corp. of America · Jul 1993
GATES GLIDDEN DRILLS
K905418 · The Hygenic Corp. · Jul 1991
FILLOCK REAMER
K901097 · Ivoclar North America, Inc. · Apr 1990
ANEST-EZE DENTAL DRILL RA#2
K896149 · Signature One Products, Inc. · Jan 1990