FDA.reportPublic FDA data

MASEL

Primary DI
00190707008536
Brand
MASEL
Company
ORTHO ORGANIZERS, INC.
Model
4061-028
Device description
.028 BALL CLASPS
Published
2018-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EHPCLASP, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHPClasp, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707008536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707008536001907070085361907070085360190707008536

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic clasp, metal, preformedA prefabricated dental device made of wrought metal alloy intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth. 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
062165188
Device count
1
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190707068148VARIABLE FORCE 3™ THERMAL NITANIUM® ARCHWIRE104-9672026-01-07
10190707086494Triumph®205-0112026-01-07
00190707086503Triumph®205-206B2026-01-07
10190707086517Triumph®205-206T2026-01-07
10190707086524Triumph®205-207T2026-01-07
10190707086531Triumph®205-207TT2026-01-07
00190707102975Carriere® Motion Pro™425-818C2024-01-16
00190707103002Carriere® Motion Pro™425-820C2024-01-16
00190707103033Carriere® Motion Pro™425-823C2024-01-16
00190707103064Carriere® Motion Pro™425-825C2024-01-16
00190707103095Carriere® Motion Pro™425-827C2024-01-16
00190707075972Maestro® Band Assemblies902-351061E2020-07-14
00190707096755Reveal® Aligners139-61042022-01-06
00190707096762Reveal® Aligners139-61052022-01-06
00190707096779Reveal® Aligners139-61062022-01-06
00190707096786Reveal® Aligners139-61072022-01-06
00190707096793Reveal® Aligners139-61092022-01-06
00190707096809Reveal® Aligners139-61082022-01-06
00190707096816Reveal® Aligners139-61102022-01-06
00190707096823Reveal® Aligners139-61112022-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J01810170J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810180J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810190J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810201J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810210J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810220J-Clasp oblique Scheu-Dental GmbHEHP2024-11-19
J01810230JM-ClaspScheu-Dental GmbHEHP2024-11-19
J01810260T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810270T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810470J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810480J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01820480SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820490SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820500SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820510SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820520SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820530SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820550Arrow ClaspScheu-Dental GmbHEHP2024-11-19
J01820560Arrow ClaspScheu-Dental GmbHEHP2024-11-19
J01821040Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821050Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821060Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821070Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821080Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821090Adams ClaspScheu-Dental GmbHEHP2024-11-19
00000008857972RMORmo, Inc.EHP2024-08-12
D772198150BALL CLASPS 2000 AMERICAN TOOTH INDUSTRIESEHP2023-08-30
D772ATI0131981560BALL CLASP 2000AMERICAN TOOTH INDUSTRIESEHP2023-08-30
D772ATI198140BALL CLASPS 2000AMERICAN TOOTH INDUSTRIESEHP2023-08-30
H66810091500ItsoClearKeystone IndustriesEHP2022-11-30