FDA.reportPublic FDA data

A-FIT®

Primary DI
E53581363600001
Brand
A-FIT®
Company
Gc Orthodontics America Inc.
Model
81-3636-0000
Catalog number
81-3636-0000
Device description
A-FIT® 1. MOLAR LWR LFT SZ 36
Published
2017-06-30
Public version status
Update
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
DYOBAND, MATERIAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYOBand, Material, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E53581363600001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to 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 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

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