FDA.reportPublic FDA data

3M™ Imprint™

Primary DI
04054596645714
Brand
3M™ Imprint™
Company
3M Deutschland GmbH
Model
71494
Catalog number
71494
Device description
3M™ Imprint™ 4 VPS Impression Material Penta™ Heavy Body, 71494, Intro Kit, 1 Each/Pack
Published
2022-08-02
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
04054596645714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054596645714040545966457144054596645714

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-39573Mhealthcarecompliance@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
false
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
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
00850078989369SmileSet Impression Kit - RetainerOrtho Dental Lab LLCELW2026-03-20
00850078989376SmileSet Impression Kit - Night GuardOrtho Dental Lab LLCELW2026-03-20
00860014754630Owl Impression KitOWL DENTAL LAB INCELW2026-03-05
E241AA9050Cavex CleverCast - Slow SetCavex Holland B.V.ELW2026-03-05
08719327516010Cavex CleverCast - Normal SetCavex Holland B.V.ELW2026-03-05
E241AA6050Cavex Cream FastCavex Holland B.V.ELW2026-03-04
E241AA6051Cavex Cream Fast Cavex Holland B.V.ELW2026-03-04
07630243601684AdhesiveDent4You AGELW2026-02-10
07630243601691AdhesiveDent4You AGELW2026-02-10
00850079280427CAvexHexa DentalELW2026-01-22
00850079280014One PlusHexa DentalELW2026-01-21
00085007928014One PlusHexa DentalELW2026-01-21
00850057092240HexaHexa DentalELW2026-01-21
00850057092929One PlusHexa DentalELW2026-01-21
00850057092936One PlusHexa DentalELW2026-01-21
00850057092943One PlusHexa DentalELW2026-01-21
00850057092950One PlusHexa DentalELW2026-01-21
00850057092967One PlusHexa DentalELW2026-01-21
00850057092974One PlusHexa DentalELW2026-01-21
00850057092981One PlusHexa DentalELW2026-01-21
00850079280007One PlusHexa DentalELW2026-01-21
00850079280021One PlusHexa DentalELW2026-01-21
00850079280304CavexHexa DentalELW2026-01-21
00850079280311cAVEXHexa DentalELW2026-01-21
00850079280328CavexHexa DentalELW2026-01-21
00850079280335CavexHexa DentalELW2026-01-21
00850079280342CavexHexa DentalELW2026-01-21
00850079280359CavexHexa DentalELW2026-01-21
00850057092714Hexa DentalHexa DentalELW2026-01-19
00850057092721Hexa dentalHexa DentalELW2026-01-19