S-8 O

GUDID J021101008020

Micro-Saw-Handpiece oscillating

W & H Dentalwerk Bürmoos GmbH

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: J021101008020
• NIH Device Record Key: e9ea95f5-39d9-4242-847f-01a5e44a555b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-8 O
• Version Model Number: 10100802
• Company DUNS: 300238441
• Company Name: W & H Dentalwerk Bürmoos GmbH
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J021101008020 [Direct Marking]
HIBCC	J021101008021 [Primary]

FDA Product Code

• KMW: Handpiece, Rotary Bone Cutting

Sterilization

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

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

[J021101008020]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-03
• Device Publish Date: 2025-08-26

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• J021305030021 - Piezomed Pro Accessory: 2025-09-30 Instrument MR2-S
• J021305030031 - Piezomed Pro Accessory: 2025-09-30 Instrument MR3-S
• J021305030041 - Piezomed Pro Accessory: 2025-09-30 Instrument MR4-S
• J021305030051 - Piezomed Pro Accessory: 2025-09-30 Instrument MR5-S
• J021305030061 - Piezomed Pro Accessory: 2025-09-30 Instrument MR6-S
• J021305030071 - Piezomed Pro Accessory: 2025-09-30 Instrument MS1-S