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510(k) K894358

Device
LUMINA ORTHODONTIC BRACKET
Applicant
ORMCO CORP.
510(k) number
K894358
Product code
EJF  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-15
Date received
1989-07-14
Regulation
872.5410
Classification name
Bracket, Metal, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FRANCES ZEE
Address
1332 S. Lone Hill Ave. Glendora CA US 91740 91740

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EJF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.2000-03-14
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
K925028FORESTADENT ORTHODONTIC BANDSForestadent1994-01-26
K926427LARIAT PALATE EXPANDEREasy Access Orthodontics, Inc.1994-01-26
K930881CHANNEL-EDGE BRACKET SYSTEMDualtek, Inc.1994-01-21
K933758REGENCY PLUS BRACKETMid-American Dental Specialties, Inc.1994-01-18
K922806ORMCO SPORTSGUARDOrmco Corp.1993-10-20
K923218NITANIUM PALATAL EXPANDEROrtho Organizers, Inc.1993-09-13

Legacy Summary#

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FDA Review#

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