FDA.reportPublic FDA data

RelyX™ Fiber Post 3D

Primary DI
04035077010191
Brand
RelyX™ Fiber Post 3D
Company
3M Deutschland GmbH
Model
56958
Catalog number
56958
Device description
3M™ ESPE™ RelyX™ Fiber Post 3D Trial Kit/RelyX™ Unicem 2, 56958. Sterilization prior to use only for RelyX Fiber Post Drills. Do not sterilize either RelyX Unicem 2 Automix nor RelyX Fiber Posts.
Published
2017-08-04
Public version status
Update
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
DZADRILL, DENTAL, INTRAORAL
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
ELRPOST, ROOT CANAL
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1
EIDSyringe, Restorative And Impression MaterialDental1
ELRPost, Root CanalDental1
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035077010191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035077010191040350770101914035077010191

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing nozzleA device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
315731711
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

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507073878180553M™ Tegaderm™1688NS1688NS2026-05-08
507073878180623M™ Tegaderm™1685NS1685NS2026-05-08
507073878180793M™ Tegaderm™1683NS1683NS2026-05-08
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007073878101223M™ Micropore™1530SS-11530SS-12026-05-08
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