FDA.reportPublic FDA data

3M™ RelyX™

Primary DI
04054596876699
Brand
3M™ RelyX™
Company
3M Deutschland GmbH
Model
56919
Catalog number
56919
Device description
3M™ RelyX™ Unicem 2 Automix Mixing Tips Wide and Endo, 56919
Published
2023-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
04054596876699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054596876699040545968766994054596876699

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
307073877737323M™ Coban™2094N2094N2026-05-08
307073877737493M™ Coban™2794N2794N2026-05-08
340467190223813M™ Coban™209420942026-05-08
507073878180243M™ Tegaderm™1624WNS1624WNS2026-05-08
507073878180313M™ Tegaderm™1626WNS1626WNS2026-05-08
507073878180483M™ Tegaderm™1628NS1628NS2026-05-08
507073878180553M™ Tegaderm™1688NS1688NS2026-05-08
507073878180623M™ Tegaderm™1685NS1685NS2026-05-08
507073878180793M™ Tegaderm™1683NS1683NS2026-05-08
007073874969683M™CMW06CMW062026-05-08
007073874969753M™CMW04CMW042026-05-08
007073874969823M™CMW03CMW032026-05-08
007073874969993M™CMW02CMW022026-05-08
007073878101223M™ Micropore™1530SS-11530SS-12026-05-08
040467192917003M™ Coban™2794E2794E2026-05-08
040545960049553M™ Coban™209220922026-05-08
040545966458133M™71507715072026-05-08
040545967341423M™ Penta™77944779442026-05-08
040545967342273M™ Penta™76994769942026-05-08
040545967359103M™ Impregum™P31779P317792026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28
08056000372311Mixing TipsZHERMACK SPAEID2025-03-28
08056000372328Mixing TipsZHERMACK SPAEID2025-03-28
J014656875140IOT white 96Kulzer GmbHEID2024-09-09
J014660007820IOT yellow 96Kulzer GmbHEID2024-09-09
J014660009050BITE REG INTRAORAL TIP CD 96Kulzer GmbHEID2024-09-09
J014660019880Mixing Tip yellow 1:1 48Kulzer GmbHEID2024-09-09
J014660019890Mixing Tip green 1:1 48Kulzer GmbHEID2024-09-09
08800017901923DX-MixerDXM CO., LTDEID2024-06-04
08800017901978DX-MixerDXM CO., LTDEID2024-06-04
08800017902005DX-MixerDXM CO., LTDEID2024-06-04
08800017902029DX-MixerDXM CO., LTDEID2024-06-04
10810339032064SAFE DENTBGSS Company Inc.EID2024-05-01
07615208353730Clinical Accessory (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-10-25
08800017901893Dynamic MixerDXM CO., LTDEID2023-10-25
08800017901879Dynamic MixerDXM CO., LTDEID2023-10-24
08800017901848DX-MixerDXM CO., LTDEID2023-07-31
08800017901657DX-MixerDXM CO., LTDEID2023-07-26
00020221017809EXEL 1mL CARRYING AND DELIVERY SYRINGEExel InternationalEID2023-04-21
07615208339932CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
07615208379297CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
10371347010845Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-15
10371347008620Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-10