FDA.reportPublic FDA data

Molar Tube

Primary DI
00810126380104
Brand
Molar Tube
Company
Digital Dental Laboratories, Inc
Model
0104
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
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810126380104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126380104008101263801048101263801040810126380104

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

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
00840456203514JMUJMU DENTAL, INCDZD2026-06-25
00840456203521JMUJMU DENTAL, INCDZD2026-06-25
00840456203538JMUJMU DENTAL, INCDZD2026-06-25
00840456203545JMUJMU DENTAL, INCDZD2026-06-25
00840456203552JMUJMU DENTAL, INCDZD2026-06-25
00840456205297JMUJMU DENTAL, INCDZD2026-06-25
00840456205303JMUJMU DENTAL, INCDZD2026-06-25
00840456205310JMUJMU DENTAL, INCDZD2026-06-25
00840456205327JMUJMU DENTAL, INCDZD2026-06-25
00840456205334JMUJMU DENTAL, INCDZD2026-06-25
00840456205341JMUJMU DENTAL, INCDZD2026-06-25
00840456205358JMUJMU DENTAL, INCDZD2026-06-25
00840456205365JMUJMU DENTAL, INCDZD2026-06-25
00840456205372JMUJMU DENTAL, INCDZD2026-06-25
00840456206034JMUJMU DENTAL, INCDZD2026-06-25
00840456206041JMUJMU DENTAL, INCDZD2026-06-25
00840456206058JMUJMU DENTAL, INCDZD2026-06-25
00840456206089JMUJMU DENTAL, INCDZD2026-06-25
00840456206096JMUJMU DENTAL, INCDZD2026-06-25
00840456206102JMUJMU DENTAL, INCDZD2026-06-25
00840456206119JMUJMU DENTAL, INCDZD2026-06-25
00840456206126JMUJMU DENTAL, INCDZD2026-06-25
00840456206133JMUJMU DENTAL, INCDZD2026-06-25
00840456206140JMUJMU DENTAL, INCDZD2026-06-25
00840456206157JMUJMU DENTAL, INCDZD2026-06-25
00840456206164JMUJMU DENTAL, INCDZD2026-06-25
00840456206171JMUJMU DENTAL, INCDZD2026-06-25
00840456206188JMUJMU DENTAL, INCDZD2026-06-25
00840456206195JMUJMU DENTAL, INCDZD2026-06-25
00840456206201JMUJMU DENTAL, INCDZD2026-06-25