FDA.report

Closed Tray Impression Transfer

Primary DI
D824ITC15RC0
Brand
Closed Tray Impression Transfer
Company
SURGIKOR, LLC
Model
ITC15RC
Device description
Ø3.5mm x L15.0mm, Conical Connection, Regular Platform
Published
2017-01-31
Public version status
Update
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
D824ITC15RC0PrimaryHIBCC0

GMDN Terms

TermDefinition
Basket endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a single, double, and/or triple contiguous cylinder(s) that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080321629
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D824FRC43100Fixation OneFRC43102025-12-15
D824FRC43110Fixation OneFRC43112025-12-15
D824FRC43130Fixation OneFRC43132025-12-15
D824FRC43150Fixation OneFRC43152025-12-15
D824FRC43180Fixation OneFRC43182025-12-15
D824FRC50080Fixation OneFRC50082025-12-15
D824FRC50100Fixation OneFRC50102025-12-15
D824FRC50110Fixation OneFRC50112025-12-15
D824FRC50130Fixation OneFRC50132025-12-15
D824FRC50150Fixation OneFRC50152025-12-15
D824FRC50180Fixation OneFRC50182025-12-15
D824MU17RC20Multi-Unit AbutmentMU17RC22025-12-15
D824MU17RC30Multi-Unit AbutmentMU17RC32025-12-15
D824MU17WC20Multi-Unit AbutmentMU17WC22025-12-15
D824MU17WC30Multi-Unit AbutmentMU17WC32025-12-15
D824IRH45070Immediate Implant IRH45072024-09-16
D824IWC70110Immediate Implant IWC70112022-07-20
D824IWC70130Immediate Implant IWC70132022-07-20
D824PIWC70112Immediate Implant PackPIWC70112022-07-19
D824PIWC70130Immediate Implant PackPIWC70132022-07-19

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