ArgenIS 131415

GUDID D818131415

TiBase DX RP.3G NE

ARGEN CORPORATION, THE

Dental implant suprastructure, permanent, preformed
Primary Device IDD818131415
NIH Device Record Key4b1c4154-aa3a-4f63-80e9-f985e7105e30
Commercial Distribution Discontinuation2027-03-08
Commercial Distribution StatusIn Commercial Distribution
Brand NameArgenIS
Version Model NumberTiBase DX RP.3G NE
Catalog Number131415
Company DUNS103095543
Company NameARGEN CORPORATION, THE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD818131415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


[D818131415]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-16
Device Publish Date2023-03-08

On-Brand Devices [ArgenIS]

D818120079Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120078Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120077Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120076Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120075Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120074Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120073Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120071Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120069Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120068Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818120067Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
D818127514AngBase CAM 3.8
D818127512AngBase AO 4.5/5.0 NE
D818127511AngBase AO 4.5/5.0
D818127510AngBase AO 3.5/4.0 NE
D818127509AngBase AO 3.5/4.0
D818127505AngBase SEV 4.8 NE
D818127504AngBase SEV 4.8
D818127503AngBase SEV 4.2 NE
D818127502AngBase SEV 4.2
D818127501AngBase SEV 3.6 NE
D818127515AngBase CAM 3.8 NE
D818127522AngBase DX 3.8 NE
D818127521AngBase DX 3.8
D818127520AngBase DX 3.4 NE
D818127519AngBase DX 3.4
D818127517AngBase CAM 4.3 NE
D818127516AngBase CAM 4.3
D818127530AngBase NB 3.5 NP
D818127528AngBase NC 4.3/5.0 RP NE
D818127527AngBase NC 4.3/5.0 RP
D818127526AngBase NC 3.5 NP NE
D818127525AngBase NC 3.5 NP
D818127524AngBase DX 4.5 NE
D818127523AngBase DX 4.5
D818127544AngBase SB 3.3 NC NE
D818127543AngBase SB 3.3 NC
D818127540AngBase NR 5.0 WP NE
D818127539AngBase NR 5.0 WP
D818127538AngBase NR 4.3 RP NE
D818127537AngBase NR 4.3 RP
D818127536AngBase NR 3.5 NP NE
D818127535AngBase NR 3.5 NP
D818127533AngBase NB 4.1 RP NE
D818127532AngBase NB 4.1 RP
D818127531AngBase NB 3.5 NP NE
D818127548AngBase SS 4.8 RN
D818127546AngBase SB 4.1/4.8 RC NE
D818127545AngBase SB 4.1/4.8 RC
D818127558AngBase ZS 5.7 NE

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