FDA.report

Coredent Surgical Guide

Primary DI
D97121455360
Brand
Coredent Surgical Guide
Company
Coredent
Model
1
Device description
Surgical Guide
Published
2020-10-23
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D97121455360PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implantation drilling template, custom-madeA non-sterile, custom-made device intended to be used by a dental surgeon to guide drilling in the jawbone of a patient during the first stage of a guided dental implantation procedure for dental implant placement/fixation. It is in the form of a shaped plate with predefined hole(s) capable of being used on fully and partially edentulous patients. This is a single-use device.

Sterilization Methods

Method
Liquid Chemical

Regulatory Flags

DUNS number
004030496
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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