FDA.reportPublic FDA data

Amtouch Impression Material (VPS)

Primary DI
00850058951331
Brand
Amtouch Impression Material (VPS)
Company
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
Model
Mixing Tips - Medium & Heavy Body - 50pk
Catalog number
AMTMBHB-MT
Device description
Impression Material (VPS), Mixing Tips, Medium & Heavy Body, 50/Bag
Published
2024-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIDSyringe, Restorative And Impression Material

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850058951331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850058951331008500589513318500589513310850058951331

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

Regulatory Flags#

DUNS number
180611519
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048528987Amtouch Etchant Gel1.2ml (4 pack)AMETCH42024-05-15
00850048528994Amtouch Etchant Gel1.2ml (24 pack)AMETCH242024-05-15
00850058951003Amtouch Etchant GelJumbo Kit 25mlAMETCHJUMBO-KIT2024-05-15
00850058951010Amtouch Etchant GelJumbo Refill 25mlAMETCHJUMBO2024-05-15
00850048528338EvolusSSunsc3022023-07-03
00850048528352EvolusLSunsc3042023-07-03
00850048528345EvolusMSunsc3032023-07-03
10810109910356EvolusS/CaseSunsc302CS2023-07-03
10810109910363EvolusM/CaseSunsc303CS2023-07-03
10810109910370EvolusL/CaseSunsc304CS2023-07-03
00850058951232Amtouch ToothbrushesPrepasted - AdultAMTB-PP2024-10-17
00850058951249Amtouch Dental KitDental Hygiene Kit (5pc)AMDHK2024-10-17
00850058951256Amtouch Orthodontic KitOrthodontic Kit (8pc)AMOHK-AD2024-10-17
00850058951355Amtouch Orthodontic FlosspicksUnscented - WhiteAMOFP2024-10-17
00850048528925Amtouch Temporary Crown & Bridge MaterialA2AMTCBA22024-05-14
00850048528932Amtouch Temporary Crown & Bridge MaterialA1AMTCBA12024-05-14
00850048528864Amtouch Air/Water Syringe TipsMetal Core/White Tube - 250/BagAM001AW-WH2024-10-08
00850048528901Amtouch Air/Water Syringe TipsColor Core/Clear Tube - 250/BagAM001AW2024-10-08
00850048528918Amtouch Air/Water Syringe TipsColor Core/Clear Tube - 1000/BagAM001AW-10002024-10-08
00850058951263Amtouch Intraoral TipsYellowAM-001IOYE2024-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518346721Disposable TipMEDICLUS CO.,LTDEID2026-06-05
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28
08056000372311Mixing TipsZHERMACK SPAEID2025-03-28
08056000372328Mixing TipsZHERMACK SPAEID2025-03-28
J014656875140IOT white 96Kulzer GmbHEID2024-09-09
J014660007820IOT yellow 96Kulzer GmbHEID2024-09-09
J014660009050BITE REG INTRAORAL TIP CD 96Kulzer GmbHEID2024-09-09
J014660019880Mixing Tip yellow 1:1 48Kulzer GmbHEID2024-09-09
J014660019890Mixing Tip green 1:1 48Kulzer GmbHEID2024-09-09
08800017901923DX-MixerDXM CO., LTDEID2024-06-04
08800017901978DX-MixerDXM CO., LTDEID2024-06-04
08800017902005DX-MixerDXM CO., LTDEID2024-06-04
08800017902029DX-MixerDXM CO., LTDEID2024-06-04
10810339032064SAFE DENTBGSS Company Inc.EID2024-05-01
07615208353730Clinical Accessory (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-10-25
08800017901893Dynamic MixerDXM CO., LTDEID2023-10-25
08800017901879Dynamic MixerDXM CO., LTDEID2023-10-24
08800017901848DX-MixerDXM CO., LTDEID2023-07-31
08800017901657DX-MixerDXM CO., LTDEID2023-07-26
00020221017809EXEL 1mL CARRYING AND DELIVERY SYRINGEExel InternationalEID2023-04-21
07615208339932CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
07615208379297CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
10371347010845Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-15