FDA.reportPublic FDA data

SternVantage® Impression Mat'l Mixing tips 50 pcs.

Primary DI
00841549115936
Brand
SternVantage® Impression Mat'l Mixing tips 50 pcs.
Company
STERNGOLD DENTAL LLC
Model
220162
Device description
Mixing tips used for dispensing Stern Vantage Impression Material from auto mix cartridges.
Published
2023-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIDSyringe, Restorative And Impression Material
EIYInstrument, Filling, Plastic, Dental
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1
EIYInstrument, Filling, Plastic, DentalDental1
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K810825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K810825000POLYVINYL SILICONE IMPRESSION MATERIALDental-Material Gesellschaft1981-04-14ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841549115936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841549115936008415491159368415491159360841549115936

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-226-5660laura.greige@sterngold.com

Regulatory Flags#

DUNS number
124763728
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841549118517SternTek Duplicating Material2220122023-10-04
00841549101823ERA® DO LP Basic Kit w/ Tools SS 8114122020-07-07
00841549115042Sterngold Implant System Cortical Bone Drill 3.2mm 9055222020-07-07
00841549103841ERA® Implant Abutment Micro 0°, 4mm Cuff (AX)8124352017-03-21
00841549103889ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD)8125322017-03-21
00841549103896ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BD)8125332017-03-21
00841549103902ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BD)8125342017-03-21
00841549103919ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BD)8125352017-03-21
00841549103926ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BD)8125362017-03-21
00841549103933ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BD)8125372017-03-21
00841549103940ERA® Implant Abutment Micro 0°, 2mm Cuff (BD)8125382017-03-21
00841549103957ERA® Implant Abutment Micro 0°, 3mm Cuff (BD)8125392017-03-21
00841549103964ERA® Implant Abutment Micro 0°, 4mm Cuff (BD)8125402017-03-21
00841549103988ERA® Implant Abutment Micro 0°, 6mm Cuff (BD)8125422017-03-22
00841549103995ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (BE)8125432017-03-22
00841549104008ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BE)8125442017-03-22
00841549104015ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BE)8125452017-03-22
00841549104022ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BE)8125462017-03-22
00841549104039ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BE)8125472017-03-22
00841549104046ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BE)8125482017-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412304789Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313163Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313170Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313187Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06954454001530COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001547COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001554COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001608COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001622COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001639COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001646COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001660COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001677COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002216COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002667COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002674COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454004203COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454004210COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454007310COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010815COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010822COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010839COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010846COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454011584COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454011744COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012086COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012949COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012956COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454013137COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454014516COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26