FDA.reportPublic FDA data

RETAINER BRITE®

Primary DI
D746RB368C1
Brand
RETAINER BRITE®
Company
DENTSPLY SIRONA ORTHODONTICS INC.
Model
RB-368C
Catalog number
RB-368C
Device description
Retainer Brite® Cleaning Tablets - 1 year + Sonic
Published
2021-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFTCLEANSER, DENTURE, OVER THE COUNTER
JERCLEANER, DENTURE, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFTCleanser, Denture, Over The CounterDental1
JERCleaner, Denture, MechanicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D746RB368C1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance cleanserAn agent used to remove soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. It is normally used at home by the wearer of the appliance, and is typically supplied as tablets or crystals used to make a solution that removes and/or dissolves debris or accretions. This device may need to be used in conjunction with an electrical or mechanical cleansing device. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)372-8255Essix.Sales@dentsplysirona.com
+1(844)848-0137essix.sales@dentsplysirona.com

Regulatory Flags#

DUNS number
116903307
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D746EPOO4W1PonticEPOO4-WEPOO4-W2016-09-24
D746EPOO4Y1PonticEPOO4-YEPOO4-Y2016-09-24
D746RBTPC1RETAINER BRITE®RB-TP-CRB-TP-C2021-05-01
D746ELA6G1Lower Anterior PonticELA6-GELA6-G2016-09-24
D746ELA6W1Lower Anterior PonticELA6-WELA6-W2016-09-24
D746ELA6Y1Lower Anterior PonticELA6-YELA6-Y2016-09-24
D746EUT6W1Essix®EUT6-WEUT6-W2016-09-24
D746EUT6Y1Essix®EUT6-YEUT6-Y2016-09-24
D746PLMOG1Posterior Lower PonticPLMO-GPLMO-G2016-09-24
D746PLMOW1Posterior Lower PonticPLMO-WPLMO-W2016-09-24
D746PLMOY1Posterior Lower PonticPLMO-YPLMO-Y2016-09-24
D746PUMOG1Posterior Lower PonticPUMO-GPUMO-G2016-09-24
D746PUMOW1Posterior Lower PonticPUMO-WPUMO-W2016-09-24
D746PUMOY1Posterior Lower PonticPUMO-YPUMO-Y2016-09-24
D746SUA6W1Square Upper PonticSUA6-WSUA6-W2016-09-24
D746SUA6Y1Square Upper PonticSUA6-YSUA6-Y2016-09-24
D746TUA6G1EssixTUA6-GTUA6-G2016-09-24
D746TUA6W1EssixTUA6-WTUA6-W2016-09-24
D746TUA6Y1EssixTUA6-YTUA6-Y2016-09-24
D74640035BL1SpaceFile®40035-BL40035-BL2021-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201336JMUJMU DENTAL, INCJER2026-08-18
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00840456201411JMUJMU DENTAL, INCJER2026-08-18
00840456216477JMUJMU DENTAL, INCJER2026-08-18
00840456216484JMUJMU DENTAL, INCJER2026-08-18
00840456216491JMUJMU DENTAL, INCJER2026-08-18
00840456223819JMUJMU DENTAL, INCJER2026-08-18
00840456223826JMUJMU DENTAL, INCJER2026-08-18
00840456223833JMUJMU DENTAL, INCJER2026-08-18
00840456223840JMUJMU DENTAL, INCJER2026-08-18
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00840456223864JMUJMU DENTAL, INCJER2026-08-18
00840456223871JMUJMU DENTAL, INCJER2026-08-18
00840456223888JMUJMU DENTAL, INCJER2026-08-18
00840456223895JMUJMU DENTAL, INCJER2026-08-18
00840456223901JMUJMU DENTAL, INCJER2026-08-18
00840456223918JMUJMU DENTAL, INCJER2026-08-18
00840456223925JMUJMU DENTAL, INCJER2026-08-18
00840456223932JMUJMU DENTAL, INCJER2026-08-18
00840456223949JMUJMU DENTAL, INCJER2026-08-18
00840456223956JMUJMU DENTAL, INCJER2026-08-18
00840456223963JMUJMU DENTAL, INCJER2026-08-18
00840456223970JMUJMU DENTAL, INCJER2026-08-18
00840456223987JMUJMU DENTAL, INCJER2026-08-18