FDA.reportPublic FDA data

Band Loop Space Maintainer

Primary DI
00810126380012
Brand
Band Loop Space Maintainer
Company
Digital Dental Laboratories, Inc
Model
0012
Published
2024-07-08
Public version status
Update
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
00810126380012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126380012008101263800128101263800120810126380012

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic space maintainerA dental prosthetic replacement for prematurely lost deciduous teeth intended to prevent closure of the space before eruption of the permanent successors. It is often an urgent necessity in the buccal segment to prevent impaction of the permanent teeth and other complications.

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