FDA.reportPublic FDA data

Retainer - 6 mesh pads

Primary DI
00810126381415
Brand
Retainer - 6 mesh pads
Company
Digital Dental Laboratories, Inc
Model
1415
Published
2026-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYJRetainer, Screw Expansion, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810126381415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126381415008101263814158101263814150810126381415

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251537143
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126381118Nance - Hor Rem11182026-02-26
00810126380159Set Full Denture01592026-02-25
00810126380166Finish Full Denture01662026-02-25
00810126380173Finish Denture - 1-3 Teeth01732026-02-25
00810126380180Finish Denture - 4-7 Teeth01802026-02-25
00810126380197Finish Denture - 8+ teeth01972026-02-25
00810126380203Flipper - 1 to 2 teeth02032026-02-25
00810126380210Flipper - 3+ teeth02102026-02-25
00810126380227Casting02272026-02-25
00810126380234Set Denture - 1-3 teeth02342026-02-25
00810126380241Set Denture - 4-7 teeth02412026-02-25
00810126380258Set Denture - 8+ teeth02582026-02-25
00810126380265Unilateral Denture Teeth Included02652026-02-25
00810126380272Acetal unilateral02722026-02-25
00810126380289Framework acetal02892026-02-25
00810126380296Framework cast02962026-02-25
00810126380302Unilateral casting03022026-02-25
00810126380319Unilateral denture03192026-02-25
00810126380326Custom tray03262026-02-25
00810126380333CS 200003332026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850070544849Retainer - NaturalSprintray, Inc.DYJ2026-07-29
00850070544856Retainer - BlackSprintray, Inc.DYJ2026-07-29
00850070544863Retainer - PinkSprintray, Inc.DYJ2026-07-29
00850070544870Retainer - Neon GreenSprintray, Inc.DYJ2026-07-29
08033707106616LEONE SPALEONE SPADYJ2026-07-22
08033707106623LEONE SPALEONE SPADYJ2026-07-22
08033707106630LEONE SPALEONE SPADYJ2026-07-22
08033707106647LEONE SPALEONE SPADYJ2026-07-22
08800113200210NT-TAINERSMILECADDYJ2026-07-22
06975527188057MOLEKURShanghai Coherz Technology Co., Ltd.DYJ2026-06-04
06975527188408MOLEKURShanghai Coherz Technology Co., Ltd.DYJ2026-06-04
08033707104513LEONE SPALEONE SPADYJ2026-05-28
00840456221761JMUJMU DENTAL, INCDYJ2026-05-11
00840456221778JMUJMU DENTAL, INCDYJ2026-05-11
D775AHAD0Hawley Retainer with Adams ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHAR0Hawley Retainer with Arrow ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHBC0Hawley Retainer with Ball ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHCC0Hawley Retainer with Circumferential ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMMT0MemotainGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
00197998216633Clarity™Solventum Orthodontics CorporationDYJ2026-04-25
10371347023326Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023333Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023340Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023357Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
D775AEA0Expansion ApplianceGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775AH0Hawley RetainerGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775BKS0Keles SliderGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
00190746202766PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-04-08