Dental Pain Eraser— 510(k) K192429

Substantially Equivalent

Synapse Dental

FDA 510(k) clearance K192429 for Dental Pain Eraser, Substantially Equivalent on 2020-01-14. Applicant: Synapse Dental. Device class: Unclassified.

Clearance details

Applicant: Synapse Dental
Product code: Code LWM
Device class: Unclassified
Advisory panel: Unknown
Date received: 2019-09-05
Decision date: 2020-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LWM

K193570 — Dental Pain Eraser2020-01-17
K182947 — Dental Pain Eraser2019-03-26
K011001 — TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM2001-06-07
K935304 — 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 86701994-03-16
K935082 — 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION1994-01-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.