FDA.reportPublic FDA data

Protemp™ Plus

Primary DI
04035077004312
Brand
Protemp™ Plus
Company
3M Deutschland GmbH
Model
46961
Catalog number
46961
Device description
3M™ ESPE™ Protemp™ Plus Temporization Material Refill B3, 46961
Published
2017-08-04
Public version status
Update
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
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
04035077004312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035077004312040350770043124035077004312

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
315731711
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
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
040545969528123M™ Kerramax Care™PRD500-025PRD500-0252026-01-29
040640350844623M™ Kerramax Care™PRD500-025-B550PRD500-025-B5502026-01-29
040545969528673M™ Kerramax Care™PRD500-050PRD500-0502026-01-29
040545969528983M™ Kerramax Care™PRD500-050-B50PRD500-050-B502026-01-29
040640350845093M™ Kerramax Care™PRD500-050-B550PRD500-050-B5502026-01-29
040545969529423M™ Kerramax Care™PRD500-065PRD500-0652026-01-29
040545969529733M™ Kerramax Care™PRD500-100PRD500-1002026-01-29
040640350845613M™ Kerramax Care™PRD500-100-B550PRD500-100-B5502026-01-29
040545969530243M™ Kerramax Care™PRD500-1174PRD500-11742026-01-29
040545969530793M™ Kerramax Care™PRD500-1175PRD500-11752026-01-29
040545969531093M™ Kerramax Care™PRD500-1176PRD500-11762026-01-29
040545969531303M™ Kerramax Care™PRD500-1177PRD500-11772026-01-29
040545969531613M™ Kerramax Care™PRD500-120PRD500-1202026-01-29
040545969531923M™ Kerramax Care™PRD500-120-B50PRD500-120-B502026-01-29
040545969532223M™ Kerramax Care™PRD500-240PRD500-2402026-01-29
040545969532533M™ Kerramax Care™PRD500-240-B30PRD500-240-B302026-01-29
040545969533143M™ Kerramax Care™PRD500-380-B10PRD500-380-B102026-01-29
040545969533453M™ Kerramax Care™PRD500-380-B30PRD500-380-B302026-01-29
040545969533763M™ Kerramax Care™PRD500-600-B10PRD500-600-B102026-01-29
04035077009386Clinpro™ Glycine Prophy Powder67008670082017-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481135309MICROPRIMEZest Anchors, LLCEID2026-03-10
00840479201115CR MARK II SYRINGERELIANCE ORTHODONTIC PRODUCTS INCEID2026-02-27
00304040194782Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194799Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194805Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00371347019889Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
00841336104877Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104891Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104907Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104914Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00810126504357Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00810126504388Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00371347017786Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902265DX-MixerDXM CO., LTDEID2025-09-29
20840326424302DefendYoung Innovations, Inc.EID2025-09-05
00883205032041ExperTempULTRADENT PRODUCTS, INC.EID2025-08-23
E217172261Mixing TipsKettenbach GmbH & Co. KGEID2025-08-14
E239D49701X41Mixing tipsDreve Dentamid GmbHEID2025-08-13
00195062154119Kerr RestorativesKerr CorporationEID2025-08-08
00195062154126Kerr RestorativesKerr CorporationEID2025-08-08
00195062154133Kerr RestorativesKerr CorporationEID2025-08-08
00195062154140Kerr RestorativesKerr CorporationEID2025-08-08
00195062154157Kerr RestorativesKerr CorporationEID2025-08-08
00195062154164Kerr RestorativesKerr CorporationEID2025-08-08
E239D496041TipsDreve Dentamid GmbHEID2025-07-21
E239D49701X61Mixing tipsDreve Dentamid GmbHEID2025-07-18
00359883007201EVANESCEDEN-MAT HOLDINGS, LLCEID2025-05-30
00813909013350Dental Cartridge DispenserNOVABONE PRODUCTS, LLCEID2025-04-25
E217150221Application TipsKettenbach GmbH & Co. KGEID2025-04-03
E217150231Application TipsKettenbach GmbH & Co. KGEID2025-04-03