FDA.reportPublic FDA data

3M™

Primary DI
30605861060968
Brand
3M™
Company
3M COMPANY
Model
EXD-949
Catalog number
EXD-949
Device description
3M™ Temporary Cement
Published
2017-04-10
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
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30605861060968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3060586106096830605861060968

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
830016148
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
007073874985353M™ Cavilon™3344E3344E2022-12-08
007073877918893M™ Cavilon™3344ENS3344ENS2022-12-08
10608223630003Bair Hugger™63000630002016-09-24
10608223645007Bair Hugger™64500645002016-09-24
507073878140263M™ Ioban™8840EZ8840EZ2025-01-17
507073878140333M™ Ioban™8850EZ8850EZ2025-01-17
307073878140463M™ Ioban™8851EZ8851EZ2025-01-17
507073878140573M™ Ioban™8840EZSB8840EZSB2025-01-17
507073878140643M™ Ioban™8850EZSB8850EZSB2025-01-17
507073878140713M™ Ioban™8851EZSB8851EZSB2025-01-17
507073875674653M™861186112026-02-19
507073877738733M™861086102026-02-19
506058610858733M™6550A16550A12025-09-09
506058610858803M™6550A26550A22025-09-09
506058610858973M™6550A36550A32025-09-09
506058610859033M™6550A3.56550A3.52025-09-09
506058610859103M™6550A46550A42025-09-09
506058610859273M™6550B16550B12025-09-09
506058610859343M™6550B26550B22025-09-09
506058610859413M™6550D36550D32025-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967029472RodinPac-Dent, Inc.EMA2026-03-23
00815967029656RodinPac-Dent, Inc.EMA2026-03-23
00815967029663RodinPac-Dent, Inc.EMA2026-03-23
00815967029670RodinPac-Dent, Inc.EMA2026-03-23
00815967029687RodinPac-Dent, Inc.EMA2026-03-23
00815967029694RodinPac-Dent, Inc.EMA2026-03-23
00815967029700RodinPac-Dent, Inc.EMA2026-03-23
00815967029717RodinPac-Dent, Inc.EMA2026-03-23
00815967029724RodinPac-Dent, Inc.EMA2026-03-23
07290115050400High-Q-Bond SEB.J.M. LABORATORIES LTDEMA2026-03-20
00817169021438UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
00817169021445UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
00840479201566GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201573GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201580GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201597GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201603GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
09336472005450RIVA CEM AUTOMIXSDI LIMITEDEMA2026-02-16
09336472020965RIVA CEM AUTOMIXSDI LIMITEDEMA2026-02-16
09336472032203RIVA CEMSDI LIMITEDEMA2026-02-16
04560227803397iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803403iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803410iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803427iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803434iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803441iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803458iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803465iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803472iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803557iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09