FDA.report

Henry Schein

Primary DI
00304040109977
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701423
Catalog number
5701423
Device description
Reveal™ Aligners - Express
Published
2019-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NXCAligner, sequential

Product Code Classifications

CodeDeviceSpecialtyClass
NXCAligner, SequentialDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040109977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040109977003040401099773040401099770304040109977

GMDN Terms

TermDefinition
Orthodontic appliance system, progressiveA series of preformed teeth aligners or positioners, worn in succession and changed every few weeks, designed to influence the shape and/or function of the stomatognathic system; often used to impact a patient's appearance and self image. It is typically custom-made using computer-generated modelling based on an initial oral impression, and a consultation with an orthodontist. It is typically made of a clear hard plastic, e.g., a thermoformed polycarbonate (PC). It is typically used to correct malocclusions such as underbites, overbites, cross bites and open bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06974361420071Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.NXC2026-03-23
06974361421436Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.NXC2026-03-23
00816063023180Invisalign ARTAlign Technology, Inc.NXC2026-02-25
D175H3DMTA91MemoryTech AlignersHype Align Clear Orthodontics LimitadaNXC2026-02-10
00816063023777Invisalign Specifix Attachment SystemAlign Technology, Inc.NXC2026-02-09
00816063023784lnvisalign Specifix Attachment System (include Engagement Features)Align Technology, Inc.NXC2026-02-09
06956748701997OrthoArchWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
06956748702055Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
06956748702147Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
06956748702390SimplyClearWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
06956748709429Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
D769CMIAL0Clear MovesPARK DENTAL RESEARCH CORPNXC2025-12-16
E239D361501Primeprint Direct AlignerDreve Dentamid GmbHNXC2025-11-25
00816063021377Invisalign Go ExpressAlign Technology, Inc.NXC2025-09-15
00860014476105SmileSet Nighttime AlignersOrtho Dental Lab LLCNXC2025-09-03
00860012825509SmileSet All-Day AlignersOrtho Dental Lab LLCNXC2025-08-28
00860012168514ArchformArchform Inc.NXC2025-07-22
00860013140700Clear Force AlignersOhlendorf Co.NXC2025-06-04
00860013140717Clear Express AlignersOhlendorf Co.NXC2025-06-04
00860013903107LuxCreo Clear Aligner SystemLuxcreo IncNXC2025-04-18
00860013903114LuxCreo Clear Aligner SystemLuxcreo IncNXC2025-04-18
00816063022800Invisalign Pre-Formed Attachment System Align Technology, Inc.NXC2025-02-28
00810060226346Blue Sky Bio, LLC.BLUE SKY BIO LLCNXC2025-02-20
D769NWRET0Naturally WhitePARK DENTAL RESEARCH CORPNXC2025-01-10
006522213072483M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072553M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072623M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072793M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072863M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072933M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22