FDA.reportPublic FDA data

Chewies

Primary DI
D78855016000041
Brand
Chewies
Company
Gc Orthodontics America Inc.
Model
55-0160-0004
Catalog number
55-0160-0004
Device description
Aligner Chewies Unscented
Published
2023-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECSPUSHER, BAND, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECSPusher, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D78855016000041PrimaryHIBCC0
D78855016000040Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic aligner/retainer seater, single-useA small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(708)897-5589GCOAInfo@gcorthodontics.com

Regulatory Flags#

DUNS number
063167128
Device count
20
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D78887122400001GC Ties87-1224-000087-1224-00002021-08-26
D78887122500001GC Ties87-1225-000087-1225-00002021-08-26
D78887122600001GC Ties87-1226-000087-1226-00002021-08-26
D78887122700001GC Ties87-1227-000087-1227-00002021-08-26
D78887122800001GC Ties87-1228-000087-1228-00002021-08-26
D78887122900001GC Ties87-1229-000087-1229-00002021-08-26
D78887123000001GC Ties87-1230-000087-1230-00002021-08-26
D78887123100001GC Ties87-1231-000087-1231-00002021-08-26
D78887123200001GC Ties87-1232-000087-1232-00002021-08-26
D78887123300001GC Ties87-1233-000087-1233-00002021-08-26
D78887123400001GC Ties87-1234-000087-1234-00002021-08-26
D78887123500001GC Ties87-1235-000087-1235-00002021-08-26
E53585043111111ELASTICS85-0431-111195-0431-11112021-08-26
E53585044111111ELASTICS85-0441-111185-0441-11112021-08-26
E53585063111111ELASTICS85-0631-111185-0631-11112021-08-26
E53585064111111ELASTICS85-0641-111196-0641-11112021-08-26
E53585083111111ELASTICS85-0831-111185-0831-11112021-08-26
E53585084111111ELASTICS85-0841-111185-0841-11112021-08-26
D78889312200001ELASTIC THREAD89-3122-000089-3122-00002021-12-03
D78889313200001ELASTIC THREAD89-3132-000089-3132-00002021-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018674639Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-05-05
00840018662087Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-01-29
00840018662155Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-01-29
00190707193317Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193324Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193331Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193348Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193355Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193362Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193379Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193386Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193393Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00371347019797Advance Dental ProductsThe Atlanta Dental Supply CompanyECS2025-10-02
00371347019803Advance Dental ProductsThe Atlanta Dental Supply CompanyECS2025-10-02
00889813066041Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECS2024-11-30
00850058951362Amtouch Aligner ChewiesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECS2024-10-08
00850058951379Amtouch Aligner ChewiesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECS2024-10-08
00885797097293SchweickhardtRmo, Inc.ECS2024-08-19
00840105223597ZOLL DENTALZoll-DentalECS2024-07-29
00843471151273Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151280Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151297Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151303Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
00843471151310Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
07908611206053ORTHOCHEWIEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECS2024-02-27
08800075622747OSUNG MNDOSUNG MND Co., Ltd.ECS2024-02-19
07898506814176QuinelatoSchobell Industrial LtdaECS2023-07-05
10889950042646Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27
10889950083335Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27
10889950083373Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCECS2023-06-27