KMY

Product Code: KMY


Products Classified as KMY

1288Positioner, Tooth, PreformedPreformed Tooth Positioner.

Total Product Life Cycle (TPLC) Devices

1288Positioner, Tooth, PreformedPreformed Tooth Positioner.

FDA Consensus Standards

Positioner, Tooth, Preformed [35851]21 CFR §872.5525 🔎
Positioner, Tooth, Preformed [35869]21 CFR §872.5525 🔎

Pre-market Notifications for KMY

K942667DENT-O-CRYL ORTHODONTIC ACRYLICDENTAURAUM, INC.
K931615NITE-GUIDEORTHO-TAIN, INC.
K925064RELAX-O-GUARDAQUATEMP SERVICE CO., INC.
K924975THE ORTHOTRAINERMYOFUNCTIONAL RESEARCH CORP. PTY. LTD.
K924974THE TMJ APPLIANCEMYOFUNCTIONAL RESEARCH CORP. PTY. LTD.
K924351GLENROE ELASTIBITE STIMULATORGLENROE TECHNOLOGIES
K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERAMERICAN ORTHODONTICS
K891328PREFORMED TEMPLATE FOR TOOTH POSITIONERAMERICAN ORTHODONTICS
K833455REMOLDABLE CRANIOMANDIBULAR APPLIANCEJEFFREY H. ATTLIN
K831793AQUALIZER MOUTHPIECEMARTIN D. LERMAN
K821458DYNAMIC FUNTIONAL POSITIONERDYNAMIC FUNCTIONAL POSITIONER, INC.
K780619PREFORMED TOOTH POSITIONERTP LABORATORIES, INC.

Global Unique Device Identification Database

00851085006117Positioner, Tooth, Preformed
10888118117349POSITIONER, TOOTH, PREFORMED
10888118117332POSITIONER, TOOTH, PREFORMED
10888118117325POSITIONER, TOOTH, PREFORMED
10888118097825POSITIONER, TOOTH, PREFORMED
10888118097818POSITIONER, TOOTH, PREFORMED
10888118097801POSITIONER, TOOTH, PREFORMED
10888118097795POSITIONER, TOOTH, PREFORMED
10888118097788POSITIONER, TOOTH, PREFORMED
10888118097771POSITIONER, TOOTH, PREFORMED
D746IS25110401POSITIONER, TOOTH, PREFORMED
E22120641Positioner, Tooth, Preformed
E22120631Positioner, Tooth, Preformed
E22120621Positioner, Tooth, Preformed
E22120611Positioner, Tooth, Preformed

Maude Adverse Events

DENTAL RETAINERUNK2019-11-05
KLS MARTIN INDIVIDUAL PATIENT SOLUTIONS (IPS)KLS-MARTIN L.P.2019-05-01
IPSSPLINTKLS MANUFACTURING2019-02-18
IPSSPLINTKLS MANUFACTURING2018-12-18
SMILE DIRECT CLUB CLEAR ALIGNERSSMILEDIRECTCLUB LLC2018-11-29
SMILEDIRECTCLUBSMILEDIRECTCLUB, LLC2018-11-01
ESSIX PLUS PLASTIC 80 CT .040 (1 MM) -120MM CIRCLEDENTSPLY SIRONA ORTHODONTICS INC.2018-10-10
THORNTON ADJUSTABLE POSITIONER AM ALIGNERAIRWAY MGMT INC2018-08-08
FLAT PLANE SPLINTALLESEE ORTHODONTIC APPLIANCES2016-09-16
MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2016-06-14
MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2015-03-13
POSITIONERALLESEE ORTHODONTIC APPLIANCES2015-02-27
INVISALIGN ORTHODONTIC APPLIANCEALIGN TECHNOLOGIES2013-07-11
MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2013-02-04
POSITIONERALLESEE ORTHODONTIC APPLIANCES2012-01-11
MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2012-01-07
MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2011-12-04
NAVIGATOR GUIDEMATERIALISE DENTAL NV2011-05-13
MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2011-04-14
MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2010-08-09
MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2010-03-03
MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2009-12-17
NAVIGATOR GUIDEMATERIALISE DENTAL NV2009-12-03
TWIN BLOCKALLESEE ORTHODONTIC APPLIANCES2009-09-09
MANDIUBLAR ANTERIOR REPOSITIONING APPLIANCE (MARA)ALLESEE ORTHODONTIC APPLIANCES2008-10-03
INVISALIGN BRACES2008-04-02
INVISALIGN SYSTEM, SEQUENTIAL ALIGNERALIGN TECHNOLOGY2007-11-05
INVISALIGN SYSTEMALIGN TECHNOLOGY2006-09-01
INVISALIGN SYSTEMALIGN TECHNOLOGY2004-02-12
INVISALIGN SYSTEMALIGN TECHNOLOGY2003-01-21
*INVISALIGN TECHNOLOGY*2002-11-05
INVISALIGN SYSTEMALIGN TECHNOLOGY2001-08-07
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.