FDA.report

Risas Reveal®

Primary DI
00190707105563
Brand
Risas Reveal®
Company
ORTHO ORGANIZERS, INC.
Model
1HDBR001RI02T2000
Device description
Risas Reveal® Aligners FLEX (1 Trays)
Published
2024-01-17
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
true

Related Records

Product Codes

CodeName
NXCAligner, sequential

Product Code Classifications

CodeDeviceSpecialtyClass
NXCAligner, SequentialDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707105563PrimaryGS10

GMDN Terms

TermDefinition
Orthodontic progressive alignerA custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062165188
Device count
1
DM exempt
true
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
true
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
10190707068148VARIABLE FORCE 3™ THERMAL NITANIUM® ARCHWIRE104-9672026-01-07
10190707086494Triumph®205-0112026-01-07
00190707086503Triumph®205-206B2026-01-07
10190707086517Triumph®205-206T2026-01-07
10190707086524Triumph®205-207T2026-01-07
10190707086531Triumph®205-207TT2026-01-07
00190707102975Carriere® Motion Pro™425-818C2024-01-16
00190707103002Carriere® Motion Pro™425-820C2024-01-16
00190707103033Carriere® Motion Pro™425-823C2024-01-16
00190707103064Carriere® Motion Pro™425-825C2024-01-16
00190707103095Carriere® Motion Pro™425-827C2024-01-16
00190707075972Maestro® Band Assemblies902-351061E2020-07-14
00190707096755Reveal® Aligners139-61042022-01-06
00190707096762Reveal® Aligners139-61052022-01-06
00190707096779Reveal® Aligners139-61062022-01-06
00190707096786Reveal® Aligners139-61072022-01-06
00190707096793Reveal® Aligners139-61092022-01-06
00190707096809Reveal® Aligners139-61082022-01-06
00190707096816Reveal® Aligners139-61102022-01-06
00190707096823Reveal® Aligners139-61112022-01-06

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