FDA.reportPublic FDA data

Chewies

Primary DI
00850017524132
Brand
Chewies
Company
STRAIGHT SMILE LLC
Model
BCHW2
Device description
A tool to assist in seating aligners and retainers around teeth
Published
2022-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017524132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017524132008500175241328500175241320850017524132

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic positioner support kitA collection of devices intended to be used to facilitate use of an orthodontic teeth positioner, including placement, removal and cleaning. It typically consists of an orthodontic appliance remover, an orthodontic positioner seater, and an orthodontic appliance cleanser. The aligner, appliance or positioner is not included. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081010579
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017524224Portable UV SanitizerBYTEUVS2023-03-20
00850017524163Byte Day AlignesHBYTETrayPRS-00632022-05-31
00850017524170Byte Night AlignersNBYTETrayPRS-00632022-05-31
00850017524187Byte RetainerBYTERetainerTrayPRS-00632022-05-31
00850017524200Brightbyte Pro (wireless) Whitening KitBYTEBBP22023-09-07
00850017524064BrightBytebb2022-09-30
00850017524088Brightbyte Pro Whitening KitBYTEBBP2022-06-06
00850017524118Brightbyte Pro Refill PensBBPRP2022-06-06
00850017524002Smile StretcherBSS12022-06-02
00850017524019Impression Kit StandardKIT2022-06-02
00850017524033Impression Rekit (Small)BYTERKS2022-06-02
00850017524040Impression Rekit (Medium)BYTERKM2022-06-02
00850017524057Impression Rekit (Large) BYTERKL2022-06-02
00850017524149Retainer RetrieverBRR12022-06-02
00860000506007Byte Aligner SystemPRS-0063PRS-00632019-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
07908854000647Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000661Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000678Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000838Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000883Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000890Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001040Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001071Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001163Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22