FDA.reportPublic FDA data

Solventum™ Paradigm™

Primary DI
00197998040719
Brand
Solventum™ Paradigm™
Company
Solventum US LLC
Model
5513J
Catalog number
5513J
Device description
Solventum™ Paradigm™ VPS Impression Material, 5513J, Heavy Body, Fast Set, 50 mL, 30/PAC
Published
2026-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00197998040726PackageGS11In Commercial Distribution
00197998040719PrimaryGS10
00197998040702Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998040726001979980407261979980407260197998040726
00197998040719001979980407191979980407190197998040719
00197998040702001979980407021979980407020197998040702

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)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119004140
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998040481Solventum™ Paradigm™531153112026-10-17
00197998040511Solventum™ Paradigm™531553152026-10-17
00197998040542Solventum™ Paradigm™5313J5313J2026-10-17
00197998040573Solventum™ Paradigm™531253122026-10-17
00197998040603Solventum™ Paradigm™531353132026-10-17
00197998040658Solventum™ Paradigm™551155112026-10-17
00197998040689Solventum™ Paradigm™551355132026-10-17
00197998040764Solventum™ Paradigm™551555152026-10-17
00197998189616Solventum™ Tegaderm™90212902122026-07-15
00197998201424Solventum™ Tegaderm™90220902202026-07-15
00197998095641Transpore™1527-01527-02026-09-25
00197998095672Transpore™1527-11527-12026-09-25
00197998095702Transpore™1527-21527-22026-09-25
00197998095733Transpore™1527-31527-32026-09-25
00197998095788Transpore™1527S-11527S-12026-09-25
00197998103612Transpore™1534-1241534-1242026-09-25
00197998103636Transpore™1534S-21534S-22026-09-25
00197998164118Transpore™1527S-21527S-22026-09-25
00197998302718Solventum™21174211742026-09-25
00197998001246Solventum™ Tegaderm™1877-21001877-21002026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012026142DaybreakSleepcare LLCELW2026-10-19
00197998040481Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040511Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040542Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040573Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040603Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040658Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040689Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040764Solventum™ Paradigm™Solventum US LLCELW2026-10-17
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