FDA.reportPublic FDA data

Spandex Advanced - 3 Size Combo Kit- Pink (1 Junior/Sm, 1 Standard/Med, 1 Large)

Primary DI
D2486054661
Brand
Spandex Advanced - 3 Size Combo Kit- Pink (1 Junior/Sm, 1 Standard/Med, 1 Large)
Company
HAGER WORLDWIDE, INC.
Model
605466
Device description
Lip and cheek retractor
Published
2026-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D2486054661PrimaryHIBCC0
D2486054660Unit of UseHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
009277971
Device count
3
DM exempt
true
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D2486054630Spandex Advanced Junior/Small (Black)6054632026-06-07
D2486054640Spandex Advanced Standard/Med (Pink)6054642026-06-07
D2486054651Spandex Advanced - 3 Size Combo Kit- Black (1 Junior/Sm, 1 Standard/Med, 1 Large6054652026-06-07
D2486058711Hager Prophy Brush Regular Flat6058712026-05-12
D2486058701Hager Prophy Brush Fine Flat6058702026-05-12
D248938521Uni-Wedge Regular ( Orange)938522026-01-28
D248938520Uni-Wedge Regular ( Orange)938522026-01-28
D2481009320"""Heidi"" Protective Eyewear "1009322025-10-22
D2481009330"""Ella"" Protective Eyewear "1009332025-10-22
D2481009350"""Lucy"" Protective Eyewear "1009352025-10-22
D2483552480BurButler (5-Hole Pink Base w/Lid)3552482025-10-22
D2483552490BurButler (5-Hole Purple Base w/Lid)3552492025-10-22
D2483552500BurButler (5-Hole White Base w/Lid)3552502025-10-22
D2483552510BurButler (5-Hole Blue Base w/Lid)3552512025-10-22
D2483552550BurButler (10-Hole Orange Base w/Lid)3552552025-10-22
D2483552570BurButler (10-Hole Black Base w/Lid)3552572025-10-22
D2483552580BurButler (10-Hole Purple Base w/Lid)3552582025-10-22
D2483552590BurButler (25-Hole White Base w/Lid)3552592025-10-22
D2483552610BurButler (25-Hole Purple Base w/Lid)3552612025-10-22
D2483552630BurButler (25-Hole Orange Base w/Lid)3552632025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000250COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000885COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000892COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000908COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000915COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000922COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000939COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000946COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000953COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000960COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002001COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002308COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002315COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002803COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002810COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002827COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002834COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002841COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454004876COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005019COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005026COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006085COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006214COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006221COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006245COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006252COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006429COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454011867COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013489COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013496COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21