Lutooth Tooth Whitening Kit
NDC Package 70635-0001-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Lutooth Tooth Whitening Kit is tooth Whitening Procedure & MethodYou can find video clips of 'How to Use' at Lutooth hompage (http://www.lutooth.com)For detailed descriptions, plase refer to the user manual inside the product package. Marketed by Quorum Bio Co.,ltd, this product is identified by NDC 70635-0001 and is authorized under FDA application part356.

Identification & Billing

NDC Package Code
70635-0001-3
Package Description
2 APPLICATOR in 1 PACKAGE / 2 mL in 1 APPLICATOR (70635-0001-1)
Product Code
70635-0001
11-Digit Billing Format
70635000103

Clinical Specifications

Proprietary Name
Lutooth Tooth Whitening Kit
Dosage Form
-
Usage Information
Tooth Whitening Procedure & MethodYou can find video clips of 'How to Use' at Lutooth hompage (http://www.lutooth.com)For detailed descriptions, plase refer to the user manual inside the product package. Exercise of installationThe Use of Whitening Stick Put Cotton rollsPut the lip&cheek retractorWipe saliva with the cotton roll Apply whitening gelsInstallation & Operation of LED AcceleratorFinishing 1 Cycle Repeat (Three cycles a day)Turn on LED light without whitening gels (Optional)

Regulatory & Marketing

Labeler Name
Quorum Bio Co.,ltd
FDA Application #
part356
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
01-01-2016
Listing Expiration
12-31-2021
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70635-0001-3 identifies a specific commercial package of 2 applicator in 1 package / 2 ml in 1 applicator (70635-0001-1) of Lutooth Tooth Whitening Kit, labeled by Quorum Bio Co.,ltd. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Quorum Bio Co.,ltd on January 01, 2016. The current certification is valid through December 31, 2021.

How is this Quorum Bio Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70635000103. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
70635-0001-3
11-Digit CMS (5-4-2)
70635-0001-03

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.