FDA.reportPublic FDA data

Solventum™ Photac™ Fil Quick Aplicap™

Primary DI
00197998118265
Brand
Solventum™ Photac™ Fil Quick Aplicap™
Company
Solventum Germany GmbH
Model
61083
Catalog number
61083
Device description
Solventum™ Photac™ Fil Quick Aplicap™ Light-Curing Glass Ionomer Dental Restorative, 61083, NP A3, 20 x 0.41 g, 50/PAC
Published
2026-11-05
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998118265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998118265001979981182651979981182650197998118265

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
00197998118227Solventum™ Photac™ Fil Quick Aplicap™61010610102026-11-05
00197998118234Solventum™ Photac™ Fil Quick Aplicap™61040610402026-11-05
00197998118241Solventum™ Photac™ Fil Quick Aplicap™61082610822026-11-05
00197998118258Solventum™ Photac™ Fil Quick Aplicap™61050610502026-11-05
00197998118623Solventum™ Photac™ Fil Quick Aplicap™61084610842026-11-05
00197998118630Solventum™ Photac™ Fil Quick Aplicap™61070610702026-11-05
00197998226700Solventum™ Garant™71453714532026-11-05
00197998288517Solventum™ Tegaderm™16006160062026-11-01
00197998288555Solventum™ Tegaderm™16004160042026-11-01
00197998288593Solventum™ Tegaderm™16002160022026-11-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998118227Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118234Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118241Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118258Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118623Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118630Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00195062160110NX3Kerr CorporationEMA2026-10-29
00195062159787BreezeKerr CorporationEMA2026-10-27
00195062159794Breeze RMGIKerr CorporationEMA2026-10-27
00197998079917Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079955Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079962Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079986Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079993Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998080005Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998099984Solventum™ RelyX™Solventum Germany GmbHEMA2026-10-08
00197998226724Solventum™ Protemp™Solventum Germany GmbHEMA2026-10-08
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20