Zubler USA PKDZLZ

GUDID D815PKDZLZ0

Chairside rotary tool adjustment kit for crowns. Kit contains discs (LXZW), points (NCFW), and burs (HGDH)

OPA DENTAL LLC

Dental abrasive disk, single-use

• Primary Device ID: D815PKDZLZ0
• NIH Device Record Key: 91ebd775-31db-4072-b276-a16f1616baa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zubler USA
• Version Model Number: PKDZLZ
• Catalog Number: PKDZLZ
• Company DUNS: 053308044
• Company Name: OPA DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
HIBCC	D815PKDZLZ0 [Primary]

FDA Product Code

• EHJ: Disk, Abrasive

Sterilization

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

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

[D815PKDZLZ0]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-12
• Device Publish Date: 2020-06-04

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