FDA.reportPublic FDA data

Small Endo Ultra Tip Kit

Primary DI
10818207022131
Brand
Small Endo Ultra Tip Kit
Company
Vista Dental
Model
407706
Published
2022-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JETPick, Massaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JETPick, MassagingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818207022131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081820702213110818207022131

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.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10818207024968Traxodent Gel AlCl - Bulk Syringe Kit90071012025-06-30
10818207024975Traxodent Gel AlCl - Sample Pack90071042025-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800019151289PVS TipB& L Biotech, inc.JET2025-04-30
08800019151296PVS TipB& L Biotech, inc.JET2025-04-30
08800019151302PVS TipB& L Biotech, inc.JET2025-04-30
08800019151593DB TipB& L Biotech, inc.JET2025-04-30
08800019151609DB TipB& L Biotech, inc.JET2025-04-30
08800019151616DB TipB& L Biotech, inc.JET2025-04-30
08800019151623DB TipB& L Biotech, inc.JET2025-04-30
08800019151630DS TipB& L Biotech, inc.JET2025-04-30
08800019151647DS TipB& L Biotech, inc.JET2025-04-30
08800019151654DS TipB& L Biotech, inc.JET2025-04-30
08800019151661DS TipB& L Biotech, inc.JET2025-04-30
08800019151678TS TipB& L Biotech, inc.JET2025-04-30
08800019151685TS TipB& L Biotech, inc.JET2025-04-30
08800019151692TS TipB& L Biotech, inc.JET2025-04-30
08800019151708TS TipB& L Biotech, inc.JET2025-04-30
08800019151715TS TipB& L Biotech, inc.JET2025-04-30
08800019151722TS TipB& L Biotech, inc.JET2025-04-30
00883205031730OpalpixULTRADENT PRODUCTS, INC.JET2025-03-12
00070942008143GUM® SUNSTAR AMERICAS, INC.JET2025-01-08
08800019151517CI Tip B& L Biotech, inc.JET2024-12-16
08800019151524CI TipB& L Biotech, inc.JET2024-12-16
08800019151319DS TipB& L Biotech, inc.JET2024-12-05
08800019151326DS TipB& L Biotech, inc.JET2024-12-05
08800019151333DS TipB& L Biotech, inc.JET2024-12-05
08800019151340DS TipB& L Biotech, inc.JET2024-12-05
08800019151357DS TipB& L Biotech, inc.JET2024-12-05
08800019151364DS TipB& L Biotech, inc.JET2024-12-05
08800019151371DS TipB& L Biotech, inc.JET2024-12-05
08800019151388DS TipB& L Biotech, inc.JET2024-12-05
00070942007849GUM® SUNSTAR AMERICAS, INC.JET2024-10-30