FDA.reportPublic FDA data

RELIABITE CHEWIE ALIGNER SEATER Y-SHAPED SOFT

Primary DI
00840479203102
Brand
RELIABITE CHEWIE ALIGNER SEATER Y-SHAPED SOFT
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
RBYSS
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PFLIntraoral, Dental Foam Protector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFLIntraoral, Dental Foam ProtectorDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840479203102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479203102008404792031028404792031020840479203102

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing surface, chairside, single-useA pad, tray, well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113170088
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D798EMHAPR0EtchmasterEMHAPR2021-07-13
D798ASK0ASKASKASK2016-07-25
D798ASKU0ASKASKUASKU2016-07-25
D798EMCO20EtchmasterEMCO2EMCO22016-09-09
D798EMGAS0EtchmasterEMGASEMGAS2016-09-03
D798EMHA0EtchmasterEMHAEMHA2016-09-03
D798EMHAR0EtchmasterEMHAREMHAR2016-09-04
D798EMTLL1EtchmasterEMTLLEMTLL2016-09-04
D798EMTLS1EtchmasterEMTLSEMTLS2016-09-04
D798EMTRL1EtchmasterEMTRLEMTRL2016-09-04
D798EMTRS1EtchmasterEMTRSEMTRS2016-09-04
D798USEP0Ultra SEPUSEP2022-03-03
D798PPA10Perfect A SmilePPA1PPA12019-09-10
D798PPD30Perfect A SmilePPD3PPD32019-09-10
D798EL240EtchantEL24EL242016-08-10
D798EL24C0EtchantEL24CEL24C2016-08-10
D798LBMPPF0LIGHT BONDLBMPPFLBMPPF2016-08-03
D798LBPP0Light BondLBPPLBPP2016-08-03
D798LBS30Light BondLBS3LBS32016-08-03
D798LBS3F0Light BondLBS3FLBS3F2016-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479203010RELIABITE CHEWIE ALIGNER SEATER ROLLRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11
00840479203027RELIABITE CHEWIE ALIGNER SEATER ROLLRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11
00840479203034RELIABITE CHEWIE ALIGNER SEATER ROLLRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11
00840479203041RELIABITE CHEWIE ALIGNER SEATER ROLLRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11
00840479203058RELIABITE CHEWIE ALIGNER SEATER Y-SHAPED FIRMRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11
00840479203065RELIABITE CHEWIE ALIGNER SEATER Y-SHAPED FIRMRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11
00840479203072RELIABITE CHEWIE ALIGNER SEATER Y-SHAPED FIRMRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11
00840479203089RELIABITE CHEWIE ALIGNER SEATER Y-SHAPED SOFTRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11
00840479203096RELIABITE CHEWIE ALIGNER SEATER Y-SHAPED SOFTRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11