FDA.report

BioBite

Primary DI
E53564201610001
Brand
BioBite
Company
Gc Orthodontics America Inc.
Model
64-2016-1000
Catalog number
64-2016-1000
Device description
BioBite SP Kit (Full Kit)
Published
2021-09-14
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

Related Records

Contact Domains

Product Codes

CodeName
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E53564201610001PrimaryHIBCC0

GMDN Terms

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

Contacts

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

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D78892500500001MULTI FA92-5005-000092-5005-00002023-03-30
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D78855016000030Chewies55-0160-000355-0160-00032023-01-25
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