FDA.reportPublic FDA data

BioBite

Primary DI
D78864201611001
Brand
BioBite
Company
Gc Orthodontics America Inc.
Model
64-2016-1100
Catalog number
64-2016-1100
Device description
BioBite SP STD 1 Pair
Published
2022-08-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D78864201611001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic springA dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(708)897-8859GCOAInfo@gcorthodontics.com

Regulatory Flags#

DUNS number
063167128
Device count
1
DM exempt
false
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D78811201CC511201EXPERIENCE11/20-1CC5-112011/20-1CC5-11202023-03-30
D78811202AA597521EXPERIENCE11/20-2AA5-975211/20-2AA5-97522023-03-30
D78812202AA519151EXPERIENCE12/20-2AA5-191512/20-2AA5-19152023-03-30
D788122C0500101EXPERIENCE12-2C05-001012-2C05-00102023-03-30
D788151CC5S0101CHIC15-1CC5-S01015-1CC5-S0102023-03-30
D788152CC5S0101CHIC15-2CC5-S01015-2CC5-S0102023-03-30
D788312BB5GP201LEGEND31-2BB5-GP2031-2BB5-GP202023-03-30
D788312CC542191LEGEND31-2CC5-421931-2CC5-42192023-03-30
D788312CC579391LEGEND31-2CC5-793931-2CC5-79392023-03-30
D78855016001550Rodney55-0160-015555-0160-01552023-03-30
D78892500100001MULTI FA92-5001-000092-5001-00002023-03-30
D78892500200001MULTI FA92-5002-000092-5002-00002023-03-30
D78892500300001MULTI FA92-5003-000092-5003-00002023-03-30
D78892500400001MULTI FA92-5004-000092-5004-00002023-03-30
D78892500500001MULTI FA92-5005-000092-5005-00002023-03-30
D78855016000010Chewies55-0160-000155-0160-00012023-01-25
D78855016000020Chewies55-0160-000255-0160-00022023-01-25
D78855016000030Chewies55-0160-000355-0160-00032023-01-25
D78855016000040Chewies55-0160-000455-0160-00042023-01-25
D78811202AA525611EXPERIENCE11/20-2AA5-256111/20-2AA5-25612023-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611204349CLASS II CORRECTOR - ICERAM CLEAR DISTALIZER - 23MM - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADYJ2026-05-26
07908611204356CLASS II CORRECTOR - ICERAM CLEAR DISTALIZER - 25MM - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADYJ2026-05-26
07908611204363CLASS II CORRECTOR - ICERAM CLEAR DISTALIZER - 27MM - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADYJ2026-05-26
00190746067549PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746067563PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746067587PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746153273PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746202742PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
00190746202759PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-03-24
EDET047541dx retainer 5 kgDETAX GmbHDYJ2026-03-06
EDET047551dx retainer 1000gDETAX GmbHDYJ2026-03-06
00810126381330Bihelix - RemovableDigital Dental Laboratories, IncDYJ2026-02-25
00810126381347Daytime applianceDigital Dental Laboratories, IncDYJ2026-02-25
00810126381354Inman spring alignerDigital Dental Laboratories, IncDYJ2026-02-25
00810126381408Retainer - 3 to 3 with meshDigital Dental Laboratories, IncDYJ2026-02-25
00810126381415Retainer - 6 mesh padsDigital Dental Laboratories, IncDYJ2026-02-25
00810126381446Retainer - lower clipDigital Dental Laboratories, IncDYJ2026-02-25
00810126381460Retainer - unsolderedDigital Dental Laboratories, IncDYJ2026-02-25
00810126381477Retainer - wrapDigital Dental Laboratories, IncDYJ2026-02-25
00810126381484Retainer- Soldered 2 arrow head claspsDigital Dental Laboratories, IncDYJ2026-02-25
00810126381491Retainer with mushroom springDigital Dental Laboratories, IncDYJ2026-02-25
00810126381538Twin block applianceDigital Dental Laboratories, IncDYJ2026-02-25
00810126381545Upper and lower saggitalDigital Dental Laboratories, IncDYJ2026-02-25
00810126381552Upper saggitalDigital Dental Laboratories, IncDYJ2026-02-25
09120074342118PowerScrew 12Tiger Dental GmbHDYJ2026-02-06
09120074342125PowerScrew 16Tiger Dental GmbHDYJ2026-02-06
09120074342323PowerScrew 08Tiger Dental GmbHDYJ2026-02-06
09120074343443PowerScrew 14Tiger Dental GmbHDYJ2026-02-06
09120074343467PowerScrew 10Tiger Dental GmbHDYJ2026-02-06
00190746021411Distal JetAMERICAN ORTHODONTICS CORPORATIONDYJ2026-01-28