FDA.report

Reveal®

Primary DI
00190707102876
Brand
Reveal®
Company
ORTHO ORGANIZERS, INC.
Model
140-KT1
Device description
REVEAL ARS BLOCK
Published
2022-10-17
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
EHMSTRIP, POLISHING AGENT

Product Code Classifications

CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707102876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707102876001907071028761907071028760190707102876

GMDN Terms

TermDefinition
Interproximal reduction kitA collection of devices intended to be used for interproximal reduction (IPR), which is the reduction of contact between adjacent teeth during orthodontic alignment of the teeth. Fine abrasives are typically used to minimize pressure and allow the formation of spaces between the teeth, enabling more effective therapy without excessive interproximal contact, which may prolong or complicate teeth alignment. The device may include burs, abrasive disks, abrasive strips, thickness gauges and charts for tracking of reproximation. This device is reusable, but certain items will need to be replenished.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062165188
Device count
1
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
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
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
07908738730509DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730516DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730554DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730561DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730578DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730301DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730318DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730325DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730332DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730356DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730363DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730370DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730387DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730394DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730400DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730417DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730424DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730431DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730448DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730455DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730462DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
10190707192270Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192287Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192294Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192300Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192317Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192324Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192331Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192348Galaxy™Ortho Organizers, Inc.EHM2025-10-23
00190707192358Galaxy™Ortho Organizers, Inc.EHM2025-10-23