FDA.reportPublic FDA data

MOUTH MIRROR

Primary DI
00190707066017
Brand
MOUTH MIRROR
Company
ORTHO ORGANIZERS, INC.
Model
4150-980
Device description
MOUTH MIRROR SIZE #5 WITH HOLLOW FORM HANDLE
Published
2020-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EAXMIRROR, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707066017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707066017001907070660171907070660170190707066017

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.

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
true
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
04251436934155KOHLERKohler Medizintechnik GmbHEAX2026-03-12
00840161311511Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-02-19
00840161311535Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-02-19
00840161311375Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311382Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311399Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311405Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311412Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311429Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311436Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311443Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00810126506726Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAX2025-12-16
008101265067713D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAX2025-12-16
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