Ritter Dental Implant System

GUDID ERITQSI421151

Ritter Implants GmbH & Co. KG

Screw endosteal dental implant, two-piece

• Primary Device ID: ERITQSI421151
• NIH Device Record Key: 34dd2c9f-6092-4209-a26a-7ac2a4978c73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ritter Dental Implant System
• Version Model Number: QSI-4.2-11.5
• Company DUNS: 342602800
• Company Name: Ritter Implants GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ERITQSI421151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131557

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-30

On-Brand Devices [Ritter Dental Implant System]

• ERITZSTA82: ZSTA-8
• ERITZSTA81: ZSTZ-8
• ERITZASA32: ZASA-3
• ERITZASA31: ZASA-3
• ERITZASA22: ZASA-2
• ERITZASA21: ZASA-2
• ERITZASA12: ZASA-1
• ERITZASA11: ZASA-1
• ERITZASA052: ZASA-05
• ERITZASA051: ZASA-05
• ERITXSPA11: XSPA-1
• ERITXSPA051: XSPA-05
• ERITXAZA251W1: XAZA-25-1W
• ERITXAZA25051: XAZA-25-05
• ERITXAZA151W1: XAZA-15-1W
• ERITXAZA15051: XAZA-15-05
• ERITXAPA251W1: XAPA-25-1W
• ERITXAPA25051: XAPA-25-05
• ERITXAPA151W1: XAPA-15-1W
• ERITXAPA15051: XAPA-15-05
• ERITWSPUTR1: WS-PUT-R
• ERITWSPUT1: WS-PUT
• ERITTTAO2: TTAO
• ERITTTAO1: TTAO
• ERITTST222: TST-22
• ERITTST221: TST-22
• ERITTST172: TST-17
• ERITTST171: TST-17
• ERITTST142: TST-14
• ERITTST141: TST-14
• ERITTSOT241: TSOT-24
• ERITTSCT171: TSCT-17
• ERITTSCT141: TSCT-14
• ERITTSA832: TSA-8.3
• ERITTSA831: TSA-8.3
• ERITTRU70BG1: TRU-70BG
• ERITTFI582: TFI-5-8
• ERITTFI581: TFI-5-8
• ERITTFI5162: TFI-5-16
• ERITTFI5161: TFI-5-16
• ERITTFI5132: TFI-5-13
• ERITTFI5131: TFI-5-13
• ERITTFI51152: TFI-5-11.5
• ERITTFI51151: TFI-5-11.5
• ERITTFI5102: TFI-5-10
• ERITTFI5101: TFI-5-10
• ERITTFI4282: TFI-4.2-8
• ERITTFI4281: TFI-4.2-8
• ERITTFI42162: TFI-4.2-16
• ERITTFI42161: TFI-4.2-16