Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010032042

FEI Number

3010032042

Entity Name

GC Orthodontics America Inc.

City/State/Country

Alsip, IL, US

Establishment Address

3737 W. 127th Street, Alsip, IL 60803, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

GC Orthodontics (Owner Number: 10043100)

Owner / Operator Contact Address

GC Orthodontics Inc., 3737 W. 127th Street, Alsip, IL 60803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mirrors GC KommonBase TN3 GC Ortho GC Ortho GC Orthodontics GC Ortho GC Ortho CHIC Brackets GC Ortho GC Ortho GC Ortho DentaSonic DS Interproximal Reduction GC Ortho GC Ortho Connect & GC Ortho Etching Gel GC Ortho GC Ortho Exerbites Chewing Aligner Orthosil

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2016-07-15
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2015-06-23
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2021-12-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-07-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-07-11
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2013-08-19
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2013-01-24
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2013-01-24
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2013-07-11
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2013-01-24
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2013-01-24
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2013-01-24
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2013-07-17
KCR	Facebow	Dental	Class 1	872.3220	2013-01-24
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2013-07-11
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2013-08-19
EJL	Bur, Dental	Dental	Class 1	872.3240	2013-08-19
ECT	Driver, Band, Orthodontic	Dental	Class 1	872.4565	2013-08-19
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2013-07-11
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2021-08-03
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2013-07-17
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2019-05-29
EHP	Clasp, Preformed	Dental	Class 1	872.3285	2013-07-17
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2013-08-19
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2015-07-21
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2013-08-19
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2013-08-19
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2013-07-17
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2016-07-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GC Orthodontics

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161684	Reliance Orthodontic Products, Inc.	Quantum LB	2016-10-06
K810210	Sci-Pharm, Inc.	MAGIC-TOUCH	1981-02-10
K875144	Reliance Orthodontic Products, Inc.	EXCEL FAST SET	1988-02-26
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010032042. Last updated year: 2026. Please use registration number 3010032042 when referencing this establishment in official correspondence.