FDA.reportPublic FDA data

RELIABITE CHEWIE ALIGNER SEATER ROLL

Primary DI
00840479203041
Brand
RELIABITE CHEWIE ALIGNER SEATER ROLL
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
RBS
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
00840479203041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479203041008404792030418404792030410840479203041

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
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
D798LBTPP0Light BondLBTPPLBTPP2019-01-14
D798MC20AF0Maximum CureMC20AFMC20AF2016-08-10
D798OFT20Ortho FlexTechOFT2OFT22016-08-06
D798OFTSAM0Ortho FlexTechOFTOFT2018-04-13
D798PO0Porcelain ConditionerPOPO2016-08-15
D798PPA20Perfect A SmilePPA2PPA22016-08-06
D798RSPFG1RenewRSPFGRSPFG2016-09-04
D798TC0Therma CureTCTC2016-07-27
D798UBLBPP0Ultra Band LokUBLBPPUBLBPP2016-07-25
D798UBLPP0Ultra Band LokUBLPPUBLPP2016-07-25
D7981FTLV0Flow Tain1FTLV1FTLV2020-07-19

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
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
00840479203102RELIABITE CHEWIE ALIGNER SEATER Y-SHAPED SOFTRELIANCE ORTHODONTIC PRODUCTS INCPFL2026-03-11