PS System - Anterior Kit

Primary DI
10818207024364
Brand
PS System - Anterior Kit
Company
Vista Dental
Model
6000002
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NYLHandpiece, Air-Powered, Root Canal Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYLHandpiece, Air-Powered, Root Canal IrrigationDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211721000PS SystemInter-Med, Inc.2021-12-02NYL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818207024364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081820702436410818207024364

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic lavage systemAn assembly of devices intended to enable lavage, through simultaneous irrigation and aspiration, of a prepared root canal to remove debris/bacteria. It is intended to be connected to the central vacuum line and includes appropriate vacuum line/syringe adaptor(s), tubing, and one or more suction cannulae (typically disposable). The suction cannulae are intended to draw irrigation solution to the apex of the root canal to flush the entire canal.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036623932
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850194007763Zr-P Bottle905772026-06-04
00818207020840ZrP Syringe Kit905782021-01-29
10818207024920Endo Sealer Solvent3170332026-04-22
10818207024944Endo Sealer Solvent Sample317033-M2026-04-22
00850194007862Desensify12019-12-13
00850194007893Omni Etch Ceramic Etch and Silane12019-12-13
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207025071Endocator Starter Kit4077302025-11-07
10818207025088Endocator Swabs (20pk)4077312025-11-07
10818207025064ReminGelRGEL30002025-10-09
10818207020205Vista-Cal Standard Kit5026002018-07-31
10818207020878Velvet Etch 5033152021-05-13
30818207020872Velvet Etch 5033002021-05-13
00850194007787Purify+ Gel 5 Pack12019-12-13
00850194007794Purify+ Liquid 5 Pack12019-12-13
00850194007954Purify+ Gel Single Pack12019-12-13
00850194007961Purify+ Liquid Single Pack12019-12-13
20818207020202Vista-Cal Refill Kit5026012018-07-31
00850194007466RE-GEN Cleanser1907192016-06-16
00818207020208Vista-Cal 2 pack Foil Pouch36272018-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818207024371PS System - Premolar KitVista DentalNYL2023-06-09
10818207024388PS System - Molar KitVista DentalNYL2023-06-09