FDA.reportPublic FDA data

ORTHO DENTAL LAB, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30321932933032193293ORTHO DENTAL LAB, LLC1Y2026-01-011530 Antioch Pike Antioch TN US 37013

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
00850078989154SmileSet Premium Whitening Refill – 4 Pack - 150-01221-855-604-7052support@smileset.com
00850078989161SmileSet Premium Whitening Sample Pen – 3 ml - 150-01231-855-604-7052support@smileset.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3312881627695494K220726K ClearNXC2022-03-16
3312881603037376K212496Ortho Aligner SystemNXC2021-11-04
3312881576896292K092319STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387ELW2009-09-16
3312881347368328K000629FLEXTIMEELW2000-04-05
3312881016404743
3312881126666687
3312881406584465
3312881495790079
3312881516825101
3312881555356106
3312881572583312
3312881611614359
3312881699069822
3312881946618511
3312881972874805
3312881995868914
3312882021462007

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NXC22022-03-16
ELW22009-09-16

GUDID#

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