PiezoImplant System SK-38

GUDID D894SK380

Angled Channel Driver, L (1.6 mm Hex)

Rex Implants, Inc.

Surgical screwdriver, reusable
Primary Device IDD894SK380
NIH Device Record Keyb8a185e6-79fb-49c0-9ae7-8ff924cbb8bf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiezoImplant System
Version Model NumberAngled Channel Driver, L (1.6 mm Hex)
Catalog NumberSK-38
Company DUNS080746478
Company NameRex Implants, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com
Phone614-304-3021
Emailinfo@reximplants.com

Device Dimensions

Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter
Length15.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD894SK380 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

[D894SK380]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-25
Device Publish Date2024-06-17

On-Brand Devices [PiezoImplant System]

D894R4530Custom Abutment Blank BL 2.9
D894R2380Custom Abutment Blank TL 2.9
D894R1380Custom Abutment Blank TL 1.8
D894R4030Adapter - BL 2.9 to External Hexagon (TL 1.8) H4
D894R4020Adapter - BL 2.9 to External Hexagon (TL 1.8) H3
D894R4010Adapter - BL 2.9 to External Hexagon (TL 1.8) H2
D894R4400MUA Ti Base R BL 2.9
D894R1450MUA Angled Channel Coping Screw TL 1.8 / 2.9
D894R1440MUA Digital Lab Analog TL 1.8 / 2.9
D894R1430MUA Scan Body TL 1.8 / 2.9
D894R1330Digital Lab Analog TL 1.8
D894R1320MUA Ti Base TL 1.8 / 2.9
D894R1290Scan Body TL 1.8
D894SK380Angled Channel Driver, L (1.6 mm Hex)
D894SK370Angled Channel Driver, S (1.6 mm Hex)
D894SK270Removal Carrier BL 2.9
D894SK200BL MUA Driver
D894R4660MUA Digital Lab Analog BL 2.9
D894R4650MUA Angled Channel Coping Screw BL 2.9
D894R4640MUA Ti Base AR BL 2.9
D894R4630MUA Scan Body BL 2.9
D894R4520Digital Lab Analog BL 2.9
D894R4490Scan Body BL 2.9
D894R2330Scan Body TL 2.9
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