FDA.report

Disposable 1.6mm MTA Carrier

Primary DI
10818207023701
Brand
Disposable 1.6mm MTA Carrier
Company
Vista Dental
Model
807015
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
true

Related Records

Contact Domains

Product Codes

CodeName
EKICarrier, Amalgam, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKICarrier, Amalgam, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818207023701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081820702370110818207023701

GMDN Terms

TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Sterilization Methods

Method

Contacts

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
false

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