ZENEX PLUS Fixture Set

GUDID 08800070229392

Izenimplant Co., Ltd.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 08800070229392
• NIH Device Record Key: 04dfb487-88cb-4621-a54a-c7b5133a37e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZENEX PLUS Fixture Set
• Version Model Number: ZPSM3511S
• Company DUNS: 694625347
• Company Name: Izenimplant Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
GS1	08800070229392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211090

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-09
• Device Publish Date: 2022-04-29

On-Brand Devices [ZENEX PLUS Fixture Set]

• 08800070229613: ZPSW5011S
• 08800070229606: ZPSW5010S
• 08800070229590: ZPSW5008S
• 08800070229583: ZPSW5007S
• 08800070229408: ZPSM3513S
• 08800070229392: ZPSM3511S
• 08800070229385: ZPSM3510S
• 08800070229378: ZPSM3508S
• 08800070229682: ZPSW5513S
• 08800070229675: ZPSW5511S
• 08800070229668: ZPSW5510S
• 08800070229651: ZPSW5508S
• 08800070229644: ZPSW5507S
• 08800070229637: ZPSW5015S
• 08800070229620: ZPSW5013S
• 08800070229552: ZPSR4515S
• 08800070229545: ZPSR4513S
• 08800070229538: ZPSR4511S
• 08800070229521: ZPSR4510S
• 08800070229514: ZPSR4508S
• 08800070229507: ZPSR4507S
• 08800070229477: ZPSR4015S
• 08800070229460: ZPSR4013S
• 08800070229453: ZPSR4011S
• 08800070229446: ZPSR4010S
• 08800070229439: ZPSR4008S
• 08800070229422: ZPSR4007S
• 08800070229415: ZPSM3515S
• 08800070229972: ZPTW5513S
• 08800070229965: ZPTW5511S
• 08800070229958: ZPTW5510S
• 08800070229941: ZPTW5508S
• 08800070229934: ZPTW5507S
• 08800070229927: ZPTW5015S
• 08800070229910: ZPTW5013S
• 08800070229903: ZPTW5011S
• 08800070229897: ZPTW5010S
• 08800070229880: ZPTW5008S
• 08800070229873: ZPTW5007S
• 08800070229866: ZPTR4515S
• 08800070229859: ZPTR4513S
• 08800070229842: ZPTR4511S
• 08800070229835: ZPTR4510S
• 08800070229828: ZPTR4508S
• 08800070229811: ZPTR4507S
• 08800070229804: ZPTR4015S
• 08800070229798: ZPTR4013S
• 08800070229781: ZPTR4011S
• 08800070229774: ZPTR4010S
• 08800070229767: ZPTR4008S