FDA.reportPublic FDA data

Solventum Orthodontics Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30320275783032027578Solventum Orthodontics Corporation1N2026-01-012724 South Peck Rd. Monrovia CA US 91016

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00197998216121Clarity™ - Clarity™ Digital Bonding Tray, Single Arch+1(800)228-3957regulatoryrequests@solventum.com
00197998216138Clarity™ - Clarity™ Digital Bonding Tray, Dual Arch+1(800)228-3957regulatoryrequests@solventum.com
00197998216152Clarity™ - Clarity™ Digital Bonding, Dual Arch Replacement+1(800)228-3957regulatoryrequests@solventum.com
00197998216169Clarity™ - Clarity™ Digital Bonding Tray, Single Arch Lost/Damaged+1(800)228-3957regulatoryrequests@solventum.com
00197998216176Clarity™ - Clarity™ Digital Bonding Tray , Dual Arch Lost/Damaged+1(800)228-3957regulatoryrequests@solventum.com
00197998216398Clarity™ - Clarity Aligners-Force, Single Arch+1(800)228-3957regulatoryrequests@solventum.com
00197998216428Clarity™ - Clarity Aligners-Force, Single Arch LostDamaged+1(800)228-3957regulatoryrequests@solventum.com
00197998216435Clarity™ - Clarity Aligners-Force, Dual Arch+1(800)228-3957regulatoryrequests@solventum.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3314401440934030K9705003M SUSTEL DENTAL SYSTEMEBF1997-04-30
3314401297490653K9627853M DENT SYSTEMKLE1996-08-12
3314401806897764K950514TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENTDYH1995-03-07
3314401013670435K944286METAL-LINED TRANSCEND CERAMIC BRACKETDYW1994-11-29
3314401680458036K911271ADHESIVE PRECOATED BRACKETSDYH1991-05-29
3314401833546931K880393TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVEDYH1988-03-31
3314401860426448K813180SCOTCHBOND DENTAL ADHESIVEKLE1982-01-12
3314401487308510K2340433M™ Transbond™ Orthodontic AdhesiveDYH2023-12-22
3314401706256414K2340433M™ Transbond™ Orthodontic AdhesiveDYH2023-12-22
3314401699493096K2332573M™ Clarity™Aligners with Quick AttachmentsNXC2023-09-29
3314401303233561K2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)NXC2023-05-22
3314401661299852K1921193M Clarity AlignersNXC2019-09-05
3314401052322322K1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance SystemNJM2018-03-16
3314401237588615K113197APC FLASH-FREE ADHESIVEDYH2012-02-02
3314401700827080K102803CLARITY ADVANCED CERAMIC BRACKETSNJM2011-02-17
3314402005751739K073697TRANSBOND SUPREME ADHESIVEDYH2008-02-15
3314401197806063K020394APC PLUS ADHESIVEDYH2002-04-12
3314401616152220K011154ELIPAR FREELIGHTEBZ2001-05-16
3314401323822647K001494MODIFICATION TO PROMPT L-POPKLE2000-07-07
3314401037414381
3314401044585467
3314401095256412
3314401133493939
3314401154703436
3314401167674181
3314401192783464
3314401217327525
3314401226261175
3314401273492348
3314401285045002
3314401295406073
3314401321820533
3314401335243815
3314401414129715
3314401422424293
3314401473948854
3314401484724185
3314401608850424
3314401640817876
3314401699242389
3314401744013356
3314401751383231
3314401813441284
3314401841568506
3314401875241499
3314401877551220
3314401896222144
3314402014949680
3314402062623014
3314402069268787

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYH82023-12-22
NXC32023-09-29
KLE32000-07-07
NJM22018-03-16
EBZ12001-05-16
EBF11997-04-30
DYW11994-11-29

GUDID#