ExHex AMC4

GUDID D768AMC40

Conical Abutment

KEYSTONE DENTAL, INC.

Dental implant suprastructure, permanent, preformed
Primary Device IDD768AMC40
NIH Device Record Keyf2b03bc9-e95e-43bf-b9a0-29b743074a42
Commercial Distribution StatusIn Commercial Distribution
Brand NameExHex
Version Model NumberAMC4
Catalog NumberAMC4
Company DUNS787471015
Company NameKEYSTONE DENTAL, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(781)328-3515
Emailcyoung@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD768AMC40 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[D768AMC40]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-02-11

On-Brand Devices [ExHex]

D768TSUZ90Retention Screw
D768TSU90Retention Screw
D768TSU30Retention Screw
D768TSU20Retention Screw
D768TSU10Retention Screw
D768TSHZ30Retention Screw
D768TSHZ20Retention Screw
D768TSH30Retention Screw
D768TSH20Retention Screw
D768TSH10Retention Screw
D768SMAX9NH0Passive Abutment
D768SMAX9H0Passive Abutment
D768SBBB17TT0Passive Abutment
D768SBBB160Passive Abutment
D768SBA17TT0Passive Abutment
D768SBA160Passive Abutment
D768SB17TT0Passive Abutment
D768SB160Passive Abutment
D768GSUZ30Retention Screw
D768GSU90Retention Screw
D768GSU30Retention Screw
D768GSU20Retention Screw
D768GSU10Retention Screw
D768GSS90Retention Screw
D768GSQZ30Retention Screw
D768GSQZ20Retention Screw
D768GSQ30Retention Screw
D768GSQ20Retention Screw
D768GSIT20Retention Screw
D768GSH10Retention Screw
D768GMCW10Gold Sleeve
D768GMC10Gold Sleeve
D768GCNX700Gold Sleeve
D768GCNX600Gold Sleeve
D768GCNX500Gold Sleeve
D768GCNX400Gold Sleeve
D768GCNX340Gold Sleeve
D768GCEX700Gold Sleeve
D768GCEX600Gold Sleeve
D768GCEX500Gold Sleeve
D768GCEX400Gold Sleeve
D768GCEX340Gold Sleeve
D768EPCTN603KT0EPC Abutment
D768EPCTN602KT0EPC Abutment
D768EPCTN601KT0EPC Abutment
D768EPCTN503KT0EPC Abutment
D768EPCTN502KT0EPC Abutment
D768EPCTN501KT0EPC Abutment
D768EPCTN433KT0EPC Abutment
D768EPCTN432KT0EPC Abutment
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