FDA.report

Reveal®

Primary DI
10190707105522
Brand
Reveal®
Company
ORTHO ORGANIZERS, INC.
Model
135-REM2
Device description
Reveal Retainers Remake
Published
2024-01-16
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
DYTMAINTAINER, SPACE PREFORMED, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707105525PrimaryGS10
10190707105522Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707105525001907071055251907071055250190707105525
1019070710552210190707105522

GMDN Terms

TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062165188
Device count
2
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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

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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

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00810126381644PositionerDigital Dental Laboratories, IncDYT2026-02-25
00810126381651Splint - "B"Digital Dental Laboratories, IncDYT2026-02-25
00810126381668Splint - 2 "C" ClaspsDigital Dental Laboratories, IncDYT2026-02-25
00810126381675Splint - 2 Adams ClaspsDigital Dental Laboratories, IncDYT2026-02-25
00810126381682Splint - 2 Ball ClaspsDigital Dental Laboratories, IncDYT2026-02-25
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00810126381705Splint - 4 Ball ClaspsDigital Dental Laboratories, IncDYT2026-02-25
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00810126381729Splint - BiocrylDigital Dental Laboratories, IncDYT2026-02-25
00810126381736Splint - BruxeezeDigital Dental Laboratories, IncDYT2026-02-25
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00810126381750Splint - Damon Night ApplianceDigital Dental Laboratories, IncDYT2026-02-25
00810126381767Splint - Day Positioned ApplianceDigital Dental Laboratories, IncDYT2026-02-25
00810126381774Splint - Day Positioned/AcetalDigital Dental Laboratories, IncDYT2026-02-25
00810126381781Splint - DualDigital Dental Laboratories, IncDYT2026-02-25
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00810126381811Splint - Erkoloc ProDigital Dental Laboratories, IncDYT2026-02-25
00810126381828Splint - FarrarDigital Dental Laboratories, IncDYT2026-02-25
00810126381835Splint - FlexiteDigital Dental Laboratories, IncDYT2026-02-25
00810126381842Splint - GelbDigital Dental Laboratories, IncDYT2026-02-25
00810126381859Splint - Koise DeprogrammerDigital Dental Laboratories, IncDYT2026-02-25
00810126381866Splint - LucoDigital Dental Laboratories, IncDYT2026-02-25