FDA.reportPublic FDA data

Clear Cheek Retractors

Primary DI
00190746073601
Brand
Clear Cheek Retractors
Company
AMERICAN ORTHODONTICS CORPORATION
Model
852-763
Catalog number
852-763
Device description
CHEEK RETRACTOR UNILATERAL PHOTOGRAPHIC SMALL 5/PKG
Published
2020-09-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIGRETRACTOR, ALL TYPES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746073601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746073601001907460736011907460736010190746073601

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, professional, reusableA hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
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
false
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
00190746067549PowerScope852-016539852-0165392026-03-24
00190746067563PowerScope852-016540852-0165402026-03-24
00190746067587PowerScope852-030576852-0305762026-03-24
00190746153273PowerScope852-016541852-0165412026-03-24
00190746202742PowerScope852-016538852-0165382026-03-24
00190746202759PowerScope852-016537852-0165372026-03-24
00190746191602Empower Bracket475-1112VSCC475-1112VSCC2026-03-23
00190746191619Empower Bracket475-128VSCC475-128VSCC2026-03-23
00190746191626Empower Bracket475-2112VSCC475-2112VSCC2026-03-23
00190746191633Empower Bracket475-228VSCC475-228VSCC2026-03-23
00190746191640Empower Bracket475-310VSCC475-310VSCC2026-03-23
00190746191657Empower Bracket475-410VSCC475-410VSCC2026-03-23
00190746191664Empower Bracket585-130BVSCC585-130BVSCC2026-03-23
00190746191671Empower Bracket585-140BVSCC585-140BVSCC2026-03-23
00190746191688Empower Bracket585-140VSCC585-140VSCC2026-03-23
00190746191695Empower Bracket585-230BVSCC585-230BVSCC2026-03-23
00190746191701Empower Bracket585-240BVSCC585-240BVSCC2026-03-23
00190746191718Empower Bracket585-240VSCC585-240VSCC2026-03-23
00190746191725Empower Bracket585-330BVSCC585-330BVSCC2026-03-23
00190746191732Empower Bracket585-340BVSCC585-340BVSCC2026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71000TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB71020TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB71030TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB7990TBS BASICSACME ENTERPRISE.EIG2026-05-22
00190776417567MillenniumAvalign Technologies, Inc.EIG2026-03-04
B382SD1472510000Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118280Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118290Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118300Surgical DirectSurgical Direct, Inc.EIG2026-02-16
04059453109095Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEIG2026-02-13
B382SD5750050Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD9177181010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD921052010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
00888118150608RETRACTORKLS-Martin L.P.EIG2025-12-23
00810123209712Adler Instrument CompanyAdler, Inc.EIG2025-12-12
B382SD62584SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
B382SD62585SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
B382SD62586SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
00810042124844OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
00810042124851OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
00810042124868OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
B382SD915100320Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100340Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100360Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100430Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100440Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100460Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100480Surgical DirectSurgical Direct, Inc.EIG2025-11-11
10190707191150Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
10190707191167Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23