FlowLogic Variety Kit FLVAKIT221

GUDID 00810209421380

FlowLogic 04 Deep Dive Kit, 21mm 00810209420925 (Qty:3) 00810209420949 (Qty:3)

SONENDO, INC.

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 00810209421380
• NIH Device Record Key: 022ad70b-23ac-4b3a-9c5a-09c03c264de1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowLogic Variety Kit
• Version Model Number: FG-016-00011-03
• Catalog Number: FLVAKIT221
• Company DUNS: 828894373
• Company Name: SONENDO, INC.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place
• Special Storage Condition, Specify: Between 0 and 0 *Store files in a clean, dry, and dust-free place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810209421380 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

[00810209421380]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-05
• Device Publish Date: 2025-12-26

On-Brand Devices [FlowLogic Variety Kit]

• 00810209421410: FlowLogic Variable Deep Dive Kit, 25mm 00810209421151 (Qty:3) 00810209421359 (Qty:3)
• 00810209421403: FlowLogic Variable Deep Dive Kit, 21mm 00810209421144 (Qty:3) 00810209421342 (Qty:3)
• 00810209421397: FlowLogic 04 Deep Dive Kit, 25mm 00810209420932 (Qty:3) 00810209420956 (Qty:3)
• 00810209421380: FlowLogic 04 Deep Dive Kit, 21mm 00810209420925 (Qty:3) 00810209420949 (Qty:3)
• 00810209421373: FlowLogic Variety Kit, 25mm 00810209420901 (Qty:1) 00810209420932 (Qty:1) 00810209421151 (Qty:1)
• 00810209421366: FlowLogic Variety Kit, 21mm 00810209420901 (Qty:1) 00810209420925 (Qty:1) 00810209421144 (Qty:1)