Perfit ZR

GUDID 08800099904300

Vatechacucera, Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800099904300
• NIH Device Record Key: 0c8e11ff-f862-44b8-b0e3-cfa93ffb3f0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfit ZR
• Version Model Number: NU 10 B4 W
• Company DUNS: 690045351
• Company Name: Vatechacucera, Inc.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800099904300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203499

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-24
• Device Publish Date: 2021-11-16

On-Brand Devices [Perfit ZR]

• 08800099908452: NU 30 A1 Z
• 08800099908445: NU 25 A1 Z
• 08800099908438: NU 22 A1 Z
• 08800099908421: NU 20 A1 Z
• 08800099908414: NU 18 A1 Z
• 08800099908407: NU 16 A1 Z
• 08800099908391: NU 14 A1 Z
• 08800099908384: NU 12 A1 Z
• 08800099908377: NU 10 A1 Z
• 08800099902856: NU 30 white W
• 08800099902849: NU 25 white W
• 08800099902832: NU 22 white W
• 08800099902825: NU 20 white W
• 08800099902818: NU 18 white W
• 08800099902801: NU 16 white W
• 08800099902795: NU 14 white W
• 08800099902788: NU 12 white W
• 08800099902771: NU 10 white W
• 08800099902764: NU 30 A3.5 W
• 08800099902757: NU 25 A3.5 W
• 08800099902740: NU 22 A3.5 W
• 08800099902733: NU 20 A3.5 W
• 08800099902726: NU 18 A3.5 W
• 08800099902719: NU 16 A3.5 W
• 08800099902702: NU 14 A3.5 W
• 08800099902696: NU 12 A3.5 W
• 08800099902689: NU 10 A3.5 W
• 08800099902672: NU 30 A3 W
• 08800099902665: NU 25 A3 W
• 08800099902658: NU 22 A3 W
• 08800099902641: NU 20 A3 W
• 08800099902634: NU 18 A3 W
• 08800099902627: NU 16 A3 W
• 08800099902610: NU 14 A3 W
• 08800099902603: NU 12 A3 W
• 08800099902597: NU 10 A3 W
• 08800099902580: NU 30 A2 W
• 08800099902573: NU 25 A2 W
• 08800099902566: NU 22 A2 W
• 08800099902559: NU 20 A2 W
• 08800099902542: NU 18 A2 W
• 08800099902535: NU 16 A2 W
• 08800099902528: NU 14 A2 W
• 08800099902511: NU 12 A2 W
• 08800099902504: NU 10 A2 W
• 08800099902498: NU 30 A1 W
• 08800099902481: NU 25 A1 W
• 08800099902474: NU 22 A1 W
• 08800099902467: NU 20 A1 W
• 08800099902450: NU 18 A1 W