Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LWM — Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

134 daysmedian FDA review time

340 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K193570	Dental Pain Eraser	Synapse Dental	2020-01-17	25
K192429	Dental Pain Eraser	Synapse Dental	2020-01-14	131
K182947	Dental Pain Eraser	Synapse Dental, LLC	2019-03-26	154
K011001	TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM	Satelec	2001-06-07	90
K935304	3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670	3M Company	1994-03-16	134
K935082	3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATI	3M Company	1994-01-26	96
K935085	3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITION	3M Company	1994-01-26	96
K915717	CEDETA	D-W Intl.	1992-11-23	340
K920119	3M DENTAL ELECTRONIC ANESTHESIA SYSTEM	3M Company	1992-05-22	133
K910625	ULTRACALM	Sion Technology, Inc.	1992-05-15	458
K900731	MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)	Medical Consultants Intl. , Ltd.	1990-12-17	305
K902948	COMFORTRON II (TENS)	M. D. Products	1990-12-17	165
K884586	COMFORTRON DENTAL ANESTHESIA APPARATUS	M. D. Products	1989-04-14	163
K873604	E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY	Electronic Waveform Laboratory, Inc.	1988-04-12	221
K873605	COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE	Pain Prevention Laboratory, Inc.	1987-12-30	117

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda