Atlas FDA

LWM

15 FDA 510(k) clearances · Product code

134 daysmedian time to decision
340 days90th percentile
15clearances measured

FDA profile

Official device name
Device, Electrical Dental Anesthesia
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
1996: 3 · 1997: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Dental Pain Eraser (K193570)Synapse Dental2020-01-17
Dental Pain Eraser (K192429)Synapse Dental2020-01-14
Dental Pain Eraser (K182947)Synapse Dental, LLC2019-03-26
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM (K011001)Satelec2001-06-07
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 (K935304)3M Company1994-03-16
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION (K935082)3M Company1994-01-26
3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS (K935085)3M Company1994-01-26
CEDETA (K915717)D-W Intl.1992-11-23
3M DENTAL ELECTRONIC ANESTHESIA SYSTEM (K920119)3M Company1992-05-22
ULTRACALM (K910625)Sion Technology, Inc.1992-05-15
MEDI LISS DENTAL ANALGESIA DEVICE (SBL601) (K900731)Medical Consultants Intl. , Ltd.1990-12-17
COMFORTRON II (TENS) (K902948)M. D. Products1990-12-17
COMFORTRON DENTAL ANESTHESIA APPARATUS (K884586)M. D. Products1989-04-14
E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY (K873604)Electronic Waveform Laboratory, Inc.1988-04-12
COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE (K873605)Pain Prevention Laboratory, Inc.1987-12-30

Track LWM automatically

Every clearance here is in the API, with alerts when new ones post.