ArgenIs 120069

GUDID D818120069

Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device intended to be sterilized prior to use

ARGEN CORPORATION, THE

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D818120069
• NIH Device Record Key: 1d9e4cbe-c7bd-424b-9dee-2e9e2a83effc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArgenIs
• Version Model Number: ZS TSV Final Screw
• Catalog Number: 120069
• Company DUNS: 103095543
• Company Name: ARGEN CORPORATION, THE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8584557900
• Email: argeninfo@argen.com
• Phone: 8584557900
• Email: argeninfo@argen.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D818120069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143051

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D818120069]

Dry Heat Sterilization

[D818120069]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-10-31

On-Brand Devices [ArgenIs]

• D818120079: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120078: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120077: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120076: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120075: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120074: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120073: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120071: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120069: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120068: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818120067: Dental prosthesis/implant abutment screw A non-sterile device intended to be used short- or lon
• D818127514: AngBase CAM 3.8
• D818127512: AngBase AO 4.5/5.0 NE
• D818127511: AngBase AO 4.5/5.0
• D818127510: AngBase AO 3.5/4.0 NE
• D818127509: AngBase AO 3.5/4.0
• D818127505: AngBase SEV 4.8 NE
• D818127504: AngBase SEV 4.8
• D818127503: AngBase SEV 4.2 NE
• D818127502: AngBase SEV 4.2
• D818127501: AngBase SEV 3.6 NE
• D818127515: AngBase CAM 3.8 NE
• D818127522: AngBase DX 3.8 NE
• D818127521: AngBase DX 3.8
• D818127520: AngBase DX 3.4 NE
• D818127519: AngBase DX 3.4
• D818127517: AngBase CAM 4.3 NE
• D818127516: AngBase CAM 4.3
• D818127530: AngBase NB 3.5 NP
• D818127528: AngBase NC 4.3/5.0 RP NE
• D818127527: AngBase NC 4.3/5.0 RP
• D818127526: AngBase NC 3.5 NP NE
• D818127525: AngBase NC 3.5 NP
• D818127524: AngBase DX 4.5 NE
• D818127523: AngBase DX 4.5
• D818127544: AngBase SB 3.3 NC NE
• D818127543: AngBase SB 3.3 NC
• D818127540: AngBase NR 5.0 WP NE
• D818127539: AngBase NR 5.0 WP
• D818127538: AngBase NR 4.3 RP NE
• D818127537: AngBase NR 4.3 RP
• D818127536: AngBase NR 3.5 NP NE
• D818127535: AngBase NR 3.5 NP
• D818127533: AngBase NB 4.1 RP NE
• D818127532: AngBase NB 4.1 RP
• D818127531: AngBase NB 3.5 NP NE
• D818127548: AngBase SS 4.8 RN
• D818127546: AngBase SB 4.1/4.8 RC NE
• D818127545: AngBase SB 4.1/4.8 RC
• D818127558: AngBase ZS 5.7 NE