FDA.reportPublic FDA data

Solventum™ Protemp™

Primary DI
00197998226755
Brand
Solventum™ Protemp™
Company
Solventum Germany GmbH
Model
46963
Catalog number
46963
Device description
Solventum™ Protemp™ Plus Temporization Material, 46963, A2, 67 g Paste, Mixing Tips – Blue
Published
2026-10-08
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
EBGCROWN AND BRIDGE, TEMPORARY, RESIN
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998226755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998226755001979982267551979982267550197998226755

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing nozzleA device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. 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
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
true
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
00197998054273Solventum™ Micropore™1530S-21530S-22026-10-23
00197998054327Solventum™ Micropore™1530-1181530-1182026-10-23
00197998054358Solventum™ Micropore™1530S-11530S-12026-10-23
00197998054396Solventum™ Micropore™1530SS-11530SS-12026-10-23
00197998307386Solventum™ Actisorb™ Silver 2206502206502202026-10-22
00197998307423Solventum™ Actisorb™ Silver 2201902201902202026-10-22
00197998307461Solventum™ Actisorb™ Silver 2201052201052202026-10-22
00197998115707Solventum™ Clinpro™67008670082026-10-09
00197998079917Solventum™ Durelon™38236382362026-10-08
00197998079955Solventum™ Durelon™38237382372026-10-08
00197998079962Solventum™ Durelon™38019380192026-10-08
00197998079986Solventum™ Durelon™38216382162026-10-08
00197998079993Solventum™ Durelon™38234382342026-10-08
00197998080005Solventum™ Durelon™38235382352026-10-08
00197998099984Solventum™ RelyX™56660566602026-10-08
00197998226724Solventum™ Protemp™46962469622026-10-08
00197998226731Solventum™ Protemp™46973469732026-10-08
00197998226748Solventum™ Protemp™46964469642026-10-08
00197998226762Solventum™ Protemp™46961469612026-10-08
00197998226779Solventum™ Protemp™46958469582026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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