Cleared Traditional

K820216 - ULTRA-WET

K820216 is an FDA 510(k) clearance for ULTRA-WET, manufactured by Buffalo Dental Mfg. Co., Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K820216 · Buffalo Dental Mfg. Co., Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Feb 1982
Decision
29d
Days
Class 2
Risk

K820216 is an FDA 510(k) clearance for the ULTRA-WET. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Buffalo Dental Mfg. Co., Inc. (Walker, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 29 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 Buffalo Dental Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K820216

510(k) Number K820216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1982
Decision Date February 24, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 127d · This submission: 29d
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 326
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K820216.
ODONTIC CENTRIC(BITE) REGIST. PASTE
K830044 · Wallace A. Erickson & Co. · Apr 1983
DENTAL IMPRESSION MATERIAL
K821221 · Crown Delta Corp. · Jun 1982
SYBRON/KERR MIRROR 3
K820183 · Sybron Corp. · Feb 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