Cleared Traditional

K820183 - SYBRON/KERR MIRROR 3

K820183 is an FDA 510(k) clearance for SYBRON/KERR MIRROR 3, manufactured by Sybron Corp.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K820183 · Sybron Corp. · Dental device
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Feb 1982
Decision
33d
Days
Class 2
Risk

K820183 is an FDA 510(k) clearance for the SYBRON/KERR MIRROR 3. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sybron Corp. (Walker, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sybron Corp. devices

FDA 510(k) Submission Details - K820183

510(k) Number K820183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1982
Decision Date February 24, 1982
Days to Decision 33 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 127d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 325
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K820183.
TWO COMPONENT RTV VINYL SILICONE MATER
K843145 · Crown Delta Corp. · Oct 1984
ODONTIC CENTRIC(BITE) REGIST. PASTE
K830044 · Wallace A. Erickson & Co. · Apr 1983
DENTAL IMPRESSION MATERIAL
K821221 · Crown Delta Corp. · Jun 1982
EXAFLEX IMPRESSION MATERIAL
K812406 · G-C Intl. Corp. · Oct 1981
G-C FIT-CHECKER IMPRESSION MATERIAL
K812679 · G-C Intl. Corp. · Oct 1981
SR-ALGICAP
K811867 · J. Aderer, Inc. · Oct 1981