510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011001Substantially Equivalent

Team-Up Tm Dental Electronic Anesthesia System

Satelec, Wellesley MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011001 is the FDA 510(k) clearance record for TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM, cleared for Satelec on under FDA product code LWM (Device, Electrical Dental Anesthesia). FDA records list 24 510(k) clearances for Satelec, from to . As of , FDA records show no recalls naming K011001.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LWM Device, Electrical Dental Anesthesia
Device class
Unclassified
Review panel
Unknown
Applicant
Satelec 70 Walnut St., Wellesley MA
510(k) summary
Summary
Third party review
No

Clearances, product code LWM

Trailing 12 months

FDA records hold no clearances under product code LWM in the trailing twelve months.

FDA records show no clearances under product code LWM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260