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510(k) K994357

Device
BITEM LOCK, MODELS SW006, SW012
Applicant
THERMOELASTIC TECHNOLOGIES, INC.
510(k) number
K994357
Product code
EJF  
Decision
Substantially Equivalent (SESE)
Decision date
2000-03-14
Date received
1999-12-27
Regulation
872.5410
Classification name
Bracket, Metal, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ART WARD
Address
3234 Ella Ln. New Port Riche FL US 34655 34655

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EJF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932825MICROARCH GOLD BRACKETGac Intl., Inc.1994-05-09
K933501ALASTIKUnitek Corp.1994-04-28
K923372MEMORY WIREAlthan, Inc.1994-04-22
K933080ORTHOTECH DURA-GOLD BARCKETSOrthotech1994-03-23
K935139FASCINATION CERAMIC BRACKETDentauraum, Inc.1994-02-04
K936244REGENCY BRACKETMid-American Dental Specialties, Inc.1994-02-02
K934881REFLECTIONSCdb Corp.1994-02-01
K935122DENTAURUM METAL BRACKETSDentauraum, Inc.1994-01-31
K926427LARIAT PALATE EXPANDEREasy Access Orthodontics, Inc.1994-01-26
K925028FORESTADENT ORTHODONTIC BANDSForestadent1994-01-26
K930881CHANNEL-EDGE BRACKET SYSTEMDualtek, Inc.1994-01-21
K933758REGENCY PLUS BRACKETMid-American Dental Specialties, Inc.1994-01-18
K922806ORMCO SPORTSGUARDOrmco Corp.1993-10-20
K932025ION-IMPLANTED NEO SENTALLOYGac Intl., Inc.1993-09-13
K925012PLASTIC CHAINAmerican Orthodontics1993-09-13

Legacy Summary#

summary

FDA Review#

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