FDA.report

Vista PRT (Post Removal) Endodontic EMS Tip

Primary DI
10818207022650
Brand
Vista PRT (Post Removal) Endodontic EMS Tip
Company
Vista Dental
Model
502623
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

Related Records

Contact Domains

Product Codes

CodeName
EKQPreparer, Root Canal Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKQPreparer, Root Canal EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818207022650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081820702265010818207022650

GMDN Terms

TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, endodonticAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to fragment and dislodge the debris within the dental pulp for removal during an endodontic procedure; it is not primarily intended for dental cleaning or periodontal therapy. Also referred to as an ultrasonic endodontic file or rasp, it is available in a variety of forms and sizes, and is typically made of metal. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true

Other Devices From This Company

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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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