FDA.report

LEGEND

Primary DI
D78831122000341
Brand
LEGEND
Company
Gc Orthodontics America Inc.
Model
31-1220-0034
Catalog number
31-1220-0034
Device description
LEGEND Mini VSLOT 018/UL2 8T 9A 0OF
Published
2018-03-02
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
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D78831122000341PrimaryHIBCC0
D78831122000340Unit of UseHIBCC0

GMDN Terms

TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be 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
10
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 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

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