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510(k) K011001

Device
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
Applicant
SATELEC
510(k) number
K011001
Product code
LWM  
Decision
Substantially Equivalent (SESE)
Decision date
2001-06-07
Date received
2001-03-09
Regulation
510(k) Premarket Notification
Classification name
Device, Electrical Dental Anesthesia
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEAN-LUC BOULNOIS
Address
70 Walnut St. Wellesley MA US 02481 02481

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LWM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193570Dental Pain EraserSynapse Dental2020-01-17
K192429Dental Pain EraserSynapse Dental2020-01-14
K182947Dental Pain EraserSynapse Dental, LLC2019-03-26
K9353043M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 86703M Company1994-03-16
K9350823M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION3M Company1994-01-26
K9350853M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS3M Company1994-01-26
K915717CEDETAD-W Intl.1992-11-23
K9201193M DENTAL ELECTRONIC ANESTHESIA SYSTEM3M Company1992-05-22
K910625ULTRACALMSion Technology, Inc.1992-05-15
K900731MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)Medical Consultants Intl. , Ltd.1990-12-17
K902948COMFORTRON II (TENS)M. D. Products1990-12-17
K884586COMFORTRON DENTAL ANESTHESIA APPARATUSM. D. Products1989-04-14
K873604E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRYElectronic Waveform Laboratory, Inc.1988-04-12
K873605COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USEPain Prevention Laboratory, Inc.1987-12-30

Legacy Summary#

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FDA Review#

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