FDA.report

Microdont

Primary DI
07908516835334
Brand
Microdont
Company
3R - INDUSTRIA E COMERCIO EIRELI
Model
10.309.005
Catalog number
10.309.005
Device description
Stainless Steel Diamond Strips with Gapped Center - 2,5 mm - Medium - Box w/06 pcs
Published
2022-01-17
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
true

Related Records

Product Codes

CodeName
EHMStrip, Polishing Agent

Product Code Classifications

CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898229802337PrimaryGS10
07908516835334Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07898229802337078982298023377898229802337
07908516835334079085168353347908516835334

GMDN Terms

TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
907197222
Device count
6
DM exempt
false
Premarket exempt
true
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
true

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