FDA.reportPublic FDA data

Vista RSS Mirror Handle

Primary DI
00818207024206
Brand
Vista RSS Mirror Handle
Company
Vista Dental
Model
103001
Published
2022-09-01
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

Contact Domains#

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
00818207024206Direct MarkingGS10
10818207024203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818207024206008182070242068182070242060818207024206
1081820702420310818207024203

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2626369755info@vista-dental.com

Regulatory Flags#

DUNS number
036623932
Device count
1
DM exempt
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818207024968Traxodent Gel AlCl - Bulk Syringe Kit90071012025-06-30
10818207024975Traxodent Gel AlCl - Sample Pack90071042025-06-30
10818207024982Traxodent Gel AlCl - Value Pack90071022025-06-30
10818207024999Traxodent Gel AlCl - Refill Kit90071032025-06-30
10818207025002Traxodent Gel FS - Bulk Syringe Kit90071062025-06-30
10818207025019Traxodent Gel FS - Value Pack90071072025-06-30
10818207025026Traxodent Gel FS - Refill Kit90071082025-06-30
10818207025033Traxodent Gel Brush Tips90071052025-06-30
10818207025040UniClean90071002025-06-30
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207024913RE-GEN Bioactive EndoPutty Kit5047562024-11-14
10818207024876REGEN Bioactive EndoSealer (SS MST Kit)5047542024-02-02
10818207024838Vista MST Visco Tip SS 17mm 50/cup3124112023-10-02
10818207024845Vista MST Visco Tip SS 22mm 50/cup3124122023-10-02
10818207024852Vista MST Visco Tip SS 17mm 20/cup3124132023-10-02
10818207024869Vista MST Visco Tip SS 22mm 20/cup3124142023-10-02
10818207024333VacuSeal Syringe3713A2023-06-09
10818207024340SmearOFF System (PS System)3730A2023-06-09
10818207024357PS System - Chlor-Xtra Plus Bag (40mL)803803-162023-06-09
10818207024364PS System - Anterior Kit60000022023-06-09

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Primary DI, Brand, Company table
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00840161311399Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311405Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
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00840161311443Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
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