TWINPOWER TURBINE 4H

GUDID 04548213057344

Air Driven High Speed Handpieces

J.MORITA MFG.CORP.

Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: 04548213057344
• NIH Device Record Key: 60849549-89f0-4834-928e-f9634a127870
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TWINPOWER TURBINE 4H
• Version Model Number: PAR-4HG-O-NK
• Company DUNS: 693811465
• Company Name: J.MORITA MFG.CORP.
• 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: 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
GS1	04548213057344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061701

FDA Product Code

• EFA: Handpiece, Belt And/Or Gear Driven, Dental

Sterilization

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

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

[04548213057344]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-11
• Device Publish Date: 2026-02-03

On-Brand Devices [TWINPOWER TURBINE 4H]

• 04548213057375: Air Driven High Speed Handpieces
• 04548213057368: Air Driven High Speed Handpieces
• 04548213057344: Air Driven High Speed Handpieces
• 04548213057337: Air Driven High Speed Handpieces
• 04548213057320: Air Driven High Speed Handpieces