Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1526352

FEI Number

1526352

Entity Name

SUMMIT ORTHODONTIC SERVICES, INC.

City/State/Country

Schaumburg, IL, US

Establishment Address

1131 Tower Rd, Schaumburg, IL 60173, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SUMMIT ORTHODONTIC SERVICES, INC. (Owner Number: 1526352)

Owner / Operator Contact Address

343 NORTHMORELAND AVE., --, Munroe Falls, OH 44262, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Buccal Tubes Functional Tubes Summit Long Hook Summit Short Hook Summit Clutch-Stop Tubes Malibu Tubes Stainless Steel Tubing Scotchbrite abrasive wheels ECONO CUTTER Summit Mini Cutter Steel Trim Bur Meigrit Trim Bur Summit Carbide Burs Trim Bur Abrasive Points and Trimmers Typhoon Burs Essix Wheel Saw 12-flute carbide Debonding burs Diamond burs Plaster trimmer TUNGSTEN CARBIDE BURS GOLD-COATED CARBIDE BURS Bono Trimmer Diamond Wheel Nola Extra-oral Cheek Expander Occlusal Lip Retractor Clinipix Retractor Occlusal Photo Cheek Retractor Summit Lip Ring Retractor Retract Eez Photo Cheek Retractor Spand-ezz Universal Photo Retractor Single End Cheek Retractor Lip & Cheek Retractor Stainless Steel Impression Trays Aluminum Impression Trays DISPOSABLE IMPRESSION TRAYS RIGID PLASTIC IMPRESSION TRAYS HEATLESS WHEELS Silent Stones Leone Expansion Screws Forestadent Expansion Screws Dentaurum Expansion Screw H-Screw Summit Expansion Screws Edgewise Brackets Hooks Lugs Buttons Cleats Bondable Tongue Spurs Eyelets Archwire Arrow Anchors Colboloy Wire Flatbow Retainer Forms Lingual bars Modified Arrow/Circle Clasps Lingual retainers SUMMIT ROUND AND RECTANGULAR WIRE Braided Strengthener Hawley Forms TitanMoly Wire Ball Clasps Arrow Clasps Ligature Wire Adams Clasps Ligature Ties

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2006-05-16
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2006-05-16
EJL	Bur, Dental	Dental	Class 1	872.3240	2001-11-29
EIG	Retractor, All Types	Dental	Class 1	872.4565	2001-11-29
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2001-11-29
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2006-05-16
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2001-11-29
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2006-05-16
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2001-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SUMMIT ORTHODONTIC SERVICES, INC.

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

Similar Registrations

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3006707038	MYOFUNCTIONAL RESEARCH CORP. PTY. LTD.	HELENSVALE Queensland, AU
3032027578	Solventum Orthodontics Corporation	Monrovia, CA, US
3014425175	Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, MX
3015337428	GUANGZHOU CHEER-U MATERIAL TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN
3005027553	ULTIMATE DO BRASIL IMPORTACAO E EXPORTACAO LTDA.	SAO JOSE DOS CAMPOS Sao Paulo, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1526352. Last updated year: 2026. Please use registration number 1526352 when referencing this establishment in official correspondence.