FDA.reportPublic FDA data

PiezoImplant System

Primary DI
D894SK130
Brand
PiezoImplant System
Company
Rex Implants, Inc.
Model
Fit Gauge W4-H
Catalog number
SK-13
Device description
Fit Gauge W4-H
Published
2022-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D894SK130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6146538429info@reximplants.com

Regulatory Flags#

DUNS number
080746478
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D894B2094C0PiezoImplant SystemREX BL 2.9 x 4 H9B2-094C2022-12-24
D894B2095C0PiezoImplant SystemREX BL 2.9 x 5 H9B2-095C2022-12-24
D894B2114C0PiezoImplant SystemREX BL 2.9 x 4 H11B2-114C2022-12-24
D894B2115C0PiezoImplant SystemREX BL 2.9 x 5 H11B2-115C2022-12-24
D894B2134C0PiezoImplant SystemREX BL 2.9 x 4 H13B2-134C2022-12-24
D894B2135C0PiezoImplant SystemREX BL 2.9 x 5 H13B2-135C2022-12-24
D894B2154C0PiezoImplant SystemREX BL 2.9 x 4 H15B2-154C2022-12-24
D894B2155C0PiezoImplant SystemREX BL 2.9 x 5 H15B2-155C2022-12-24
D894R4040PiezoImplant SystemRetention Screw BL 2.9R4-042022-12-30
D894R4050PiezoImplant SystemStraight Abutment BL 2.9 H1R4-052022-12-30
D894R4060PiezoImplant SystemStraight Abutment BL 2.9 H2R4-062022-12-30
D894R4070PiezoImplant SystemStraight Abutment BL 2.9 H3R4-072022-12-30
D894R4080PiezoImplant SystemCover Screw BL 2.9R4-082022-12-30
D894R4090PiezoImplant SystemImpression Pin L BL 2.9R4-092022-12-30
D894R4100PiezoImplant SystemImpression Pin S BL 2.9R4-102022-12-30
D894R4120PiezoImplant SystemLab Analog BL 2.9R4-122022-12-30
D894R4130PiezoImplant SystemHealing Abutment BL 2.9 H1R4-132022-12-30
D894R4140PiezoImplant SystemHealing Abutment BL 2.9 H2R4-142022-12-30
D894R4150PiezoImplant SystemHealing Abutment BL 2.9 H3R4-152022-12-30
D894R4160PiezoImplant SystemHealing Abutment BL 2.9 H4R4-162022-12-30

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