FDA.reportPublic FDA data

3M™ RelyX™

Primary DI
04054596812765
Brand
3M™ RelyX™
Company
3M Deutschland GmbH
Model
56978
Catalog number
56978
Device description
3M™ RelyX™ Universal Resin Cement Value Pack, 56978, A1
Published
2020-10-02
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
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054596812765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054596812765040545968127654054596812765

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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
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
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
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