FDA.reportPublic FDA data

Crystal HD® Mouth Mirrors

Primary DI
10840161306163
Brand
Crystal HD® Mouth Mirrors
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50Z372-NEON
Device description
"Resin Screw-on heads 12 pk #5 Assorted Vibrant, 40% brighter than rhodium mirrors, Lens is flush with mirror frame, eliminating the possibility of corrosion build-up, Cone Socket 2 x Neon Blue 2 x Neon Yellow 2 x Neon Green 2 x Neon Orange 2 x Neon Purple 2 x Neon Pink"
Published
2022-10-27
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
10840161306163PrimaryGS10
00840161306166Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084016130616310840161306163
00840161306166008401613061668401613061660840161306166

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter24Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064783913
Device count
12
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
00840161311511Crystal HD® Mouth Mirrors50Z364SMPL-US2026-02-19
00840161311535Crystal HD® Mouth Mirrors50Z384SMPL-US2026-02-19
00840161311559Midmark - Magnetic Bur Block - 14-Hole - Neon Blue - 1 Count50Z403N-MID2026-02-19
00840161302144Patterson Dental - Steri-Endo Guard, Endo Assist - Replacement Foam for Steri-En50Z451-PAT2026-02-19
00840161311689Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 1 Count Sample Pack50Z457SMPL-US2026-02-19
00840161311702Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample Pack50Z459SMPL-US2026-02-19
00840161311733Lingua-Fix® - Low-Volume Evacuator - 1 Count Sample Pack50Z953SMPL-US2026-02-19
00840161311740Airway Armor® - Throat Guard - 3 Count Sample Pack50Z960SMPL-US2026-02-19
00840161311764SE Cushion - Saliva Ejector Cushion - 5 Count Sample Pack50Z970SMPL-US2026-02-19
00840161311788Pink Petal™ - Saliva Ejector Holder - 3 Count Sample Pack50Z976SMPL-US50Z9762026-02-19
00840161311801Mr. Thirsty® One-Step - High Volume Evacuator - Variety 3 Count Sample P50Z989SMPL-US2026-02-19
00840161301468Steri-Endo Guard - Endo Holder - Hand - White - 1 Count50Z450A50Z450A2026-02-14
00840161301475Steri-Endo Guard - Endo Holder - Hand - Blue - 1 Count50Z450B50Z450B2026-02-14
00840161301482Steri-Endo Guard - Endo Holder - Hand - Green - 1 Count50Z450D50Z450D2026-02-14
00840161301499Steri-Endo Guard - Endo Holder - Hand - Beige - 1 Count50Z450G50Z450G2026-02-14
00840161301505Steri-Endo Guard - Endo Holder - Hand - Gray - 1 Count50Z450I50Z450I2026-02-14
00840161301512Steri-Endo Guard - Endo Holder - Hand - Plum - 1 Count50Z450E50Z450E2026-02-14
00840161301529Steri-Endo Guard - Endo Holder - Hand - Teal - 1 Count50Z450J50Z450J2026-02-14
00840161301536Steri-Endo Guard - Endo Holder - Hand - Red - 1 Count50Z450M50Z450M2026-02-14
00840161301543Steri-Endo Guard - Endo Holder - Hand - Midnight - 1 Count50Z450T50Z450T2026-02-14

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
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