STERLING

GUDID 04548213060177

J.MORITA MFG.CORP.

Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: 04548213060177
• NIH Device Record Key: bf5ec843-03e1-4564-9b86-6e2158d3e8b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERLING
• Version Model Number: BEN-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	04548213060177 [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

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

[04548213060177]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-02
• Device Publish Date: 2026-02-20

On-Brand Devices [STERLING]

• 04548213060177: BEN-4HG-O-NK
• 04548213060160: BEN-4HG-O-KV
• 04548213060153: BEN-4HEX-O-KV-45