FDA.reportPublic FDA data

ExHex

Primary DI
D768GSUZ30
Brand
ExHex
Company
KEYSTONE DENTAL, INC.
Model
GSUZ3
Catalog number
GSUZ3
Device description
Retention Screw
Published
2016-02-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070841000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070841000ENDOSSEOUS DENTAL IMPLANT SYSTEMSouthern Implants, Inc.2007-06-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D768GSUZ30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(781)328-3515cyoung@keystonedental.com
+1(866)902-9272info@keystonedental.com

Regulatory Flags#

DUNS number
787471015
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D76802538901111K0Prima02-541901111K2017-12-13
D76802541901111K0Prima02-540901111K2017-12-13
D76802550901111K0Prima15789K2017-12-13
D76815300K0Prima15300K15300K2016-02-04
D76815301K0Prima15301K15301K2016-02-04
D76815302K0Prima15302K15302K2016-02-04
D76815303K0Prima15303K15303K2016-02-04
D76815304K0Prima15304K15304K2016-02-04
D76815305K0Prima15305K15305K2016-02-04
D76815306K0Prima15306K15306K2016-02-04
D76815307K0Prima15307K15307K2016-02-04
D76815308K0Prima15308K15308K2016-02-04
D76815309K0Prima15309K15309K2016-02-04
D76815310K0Prima15310K15310K2016-02-04
D76815311K0Prima15311K15311K2016-02-04
D76815312K0Prima15312K15312K2016-02-04
D76815313K0Prima15313K15313K2016-02-04
D76815314K0Prima15314K15314K2016-02-04
D76815315K0Prima15315K15315K2016-02-04
D76815316K0Prima15316K15316K2016-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494138plant Implant System8dent Inc.NHA2026-10-15
088000968498028plant Implant System8dent Inc.NHA2026-10-15
088000968501748plant Implant System8dent Inc.NHA2026-10-15
088000968515228plant Implant System8dent Inc.NHA2026-10-15
088000968515398plant Implant System8dent Inc.NHA2026-10-15
088000968515538plant Implant System8dent Inc.NHA2026-10-15
088000968516078plant Implant System8dent Inc.NHA2026-10-15
088000968516148plant Implant System8dent Inc.NHA2026-10-15
088000968516218plant Implant System8dent Inc.NHA2026-10-15
088000968516388plant Implant System8dent Inc.NHA2026-10-15
088000968588358plant Implant System8dent Inc.NHA2026-10-15
088000968600678plant Implant System8dent Inc.NHA2026-10-15
088000968603028plant Implant System8dent Inc.NHA2026-10-15
088000968609068plant Implant System8dent Inc.NHA2026-10-15
088000968616758plant Implant System8dent Inc.NHA2026-10-15
088000968620618plant Implant System8dent Inc.NHA2026-10-15
088000968621848plant Implant System8dent Inc.NHA2026-10-15
088000968623378plant Implant System8dent Inc.NHA2026-10-15
088000968688728plant Implant System8dent Inc.NHA2026-10-15
07290114710756prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710787prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710800prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710831prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710848prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114711654prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114711661prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712026prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712170prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712651prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712668prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14