Sealing Cap (Size 10) GW-MOL-SP10

GUDID 00858395006080

Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.

SONENDO, INC.

Dental delivery system instrument unit, electric

• Primary Device ID: 00858395006080
• NIH Device Record Key: 090c2d42-8ca7-4bcf-a540-796b2b0ba17c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sealing Cap (Size 10)
• Version Model Number: FG-001-00010
• Catalog Number: GW-MOL-SP10
• Company DUNS: 828894373
• Company Name: SONENDO, INC.
• Device Count: 20
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8447663636
• Email: info@sonendo.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858395006080 [Primary]
GS1	00858395006158 [Unit of Use]

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Sealing Cap (Size 10)]

• 00858395006424: Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure I
• 00858395006080: Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure I