FDA.reportPublic FDA data

DRAKE PRECISION DENTAL LABORATORY, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30027063723002706372DRAKE PRECISION DENTAL LABORATORY, INC.1N2026-01-018510 Crown Crescent Ct CHARLOTTE NC US 28227

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
00850028222003Concinnity Aligners - The Concinnity Aligners™ are a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as an alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.Intended Use / Indications for Use:The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).7048452401bsavage@drakelab.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
680611212856742K200005Concinnity AlignersNXC2020-11-09
680611115511858
680611444442599
680611771862778
680611776101246
680611844422783
680611848595251
680612043065227
680612069999612
680611418847941
680611710793113

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NXC12020-11-09

PMN#

GUDID#