FDA.reportPublic FDA data

Uni-Wedge Regular ( Orange)

Primary DI
D248938521
Brand
Uni-Wedge Regular ( Orange)
Company
HAGER WORLDWIDE, INC.
Model
93852
Device description
Dental wedges
Published
2026-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
D248938521PrimaryHIBCC0
D248938520Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.

Regulatory Flags#

DUNS number
009277971
Device count
250
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D2486058711Hager Prophy Brush Regular Flat6058712026-05-12
D2486058701Hager Prophy Brush Fine Flat6058702026-05-12
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
D2483552640BurButler (25-Hole Black Base w/Lid)3552642025-10-22
D2483552650BurButler (25-Hole Orange Base w/ Tall Lid)3552652025-10-22
D2483552660BurButler (25-Hole Blue Base w/ Tall Lid)3552662025-10-22
D2483552670BurButler (25-Hole Purple Base w/ Tall Lid)3552672025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
D2486054610Spandex Advanced Junior (Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
D2486054620Spandex Advanced Large ( Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
07630716603658Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603672Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603689Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984601TissuePro™ Distal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984632TissuePro™ Distal Sleeve, MN Retractor Single-UseArmor Dental Corp.EIF2025-05-12
08800099963765Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963772Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963789Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963796Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963802Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963819Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963826Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963833Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963840Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963857Perfit ZRVatech mcis Co., LtdEIF2025-04-07