FDA.reportPublic FDA data

Solventum™

Primary DI
00197998018930
Brand
Solventum™
Company
Solventum Germany GmbH
Model
36716
Catalog number
36716
Device description
Solventum™ Penta™ VPS Impression Material Heavy-Bodied ConsistencyHydrophilic, 36716, 600 mL base, 120 mL catalyst, 2/PAC
Published
2026-05-08
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
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998018930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998018930001979980189301979980189300197998018930

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-2249regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
315518329
Device count
1
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
00197998344046Solventum™MS02MS022026-09-24
00197998344060Solventum™MS01MS012026-09-24
00197998344084Solventum™MS06MS062026-09-24
00197998344107Solventum™MS03MS032026-09-24
00197998344121Solventum™MS04MS042026-09-24
00197998326615Solventum™ Adaptic™MAD003MAD0032026-08-26
00197998326653Solventum™ Adaptic™MAD042MAD0422026-08-26
00197998367281Solventum™ Adaptic™MAD013MAD0132026-08-26
00197998367359Solventum™ Adaptic™MAD023MAD0232026-08-26
00197998367427Solventum™ Adaptic™MAD062MAD0622026-08-26
00197998152252Solventum™ Tegaderm™90600906002026-08-23
00197998152283Solventum™ Tegaderm™90601906012026-08-23
00197998152313Solventum™ Tegaderm™90602906022026-08-23
00197998152344Solventum™ Tegaderm™90603906032026-08-23
00197998152375Solventum™ Tegaderm™90604906042026-08-23
00197998305801Solventum™ Tegaderm™90817908172026-08-23
00197998305832Solventum™ Tegaderm™90815908152026-08-23
00197998305863Solventum™ Tegaderm™90805908052026-08-23
00197998305894Solventum™ Tegaderm™90803908032026-08-23
00197998305924Solventum™ Tegaderm™90802908022026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800024201986Implant Heavy BodySherpakoreaELW2023-08-03
08800024201948Precisil BigSherpakoreaELW2021-06-14
08800024201931Delikit Premium Light BodySherpakoreaELW2021-01-27
08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
08800024201900Delikit Light BodySherpakoreaELW2021-01-07
08800024201917Delikit Light Body FSSherpakoreaELW2021-01-07
08800024201887Delikit Heavy Body FSSherpakoreaELW2021-01-04
08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
08800024201863Deli-Bite ClearSherpakoreaELW2020-10-13
08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
08800024201795Delikit Putty RSSherpakoreaELW2020-05-12
08800024201801Delikit Putty FSSherpakoreaELW2020-05-12
08800024201696Delikit Light BodySherpakoreaELW2020-04-29
08800024201702Delikit Light BodySherpakoreaELW2020-04-29
08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201726Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201733Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201740Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201757Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201764Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201771Delikit Extra Light BodySherpakoreaELW2020-04-29
08800024201788Delikit Jumbo MonophaseSherpakoreaELW2020-04-29
08800024201665Delikit Heavy BodySherpakoreaELW2020-04-27
08800024201672Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201689Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201580Imflex Heavy BodySherpakoreaELW2020-04-08