AccessGUDID - DEVICE: Brightbyte Pro Whitening Kit (00850017524088)

GUDID

Device Identifier (DI) Information

Brand Name: Brightbyte Pro Whitening Kit
Version or Model: BYTEBBP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STRAIGHT SMILE LLC

Primary DI Number: 00850017524088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081010579 *Terms of Use

Device Description: LED teeth whitening kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31806	Tooth-bleaching acceleration unit	A heat and/or light source intended to increase the oxidative effect of tooth bleachers (e.g., oxygen peroxide, carbamide peroxide, hydrogen peroxide) during tooth whitening dental procedures. It typically consists of a dedicated electromagnetic energy source (e.g., xenon lamp, LED), which may operate within a specific wavelength range, a laser, or an electric powered heater. The device is typically used during procedures in dental offices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EEG	Heat Source For Bleaching Teeth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a90a552-ba36-492e-a4dd-09b3098f548a
Public Version Date: June 14, 2022
Public Version Number: 1
DI Record Publish Date: June 06, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 866-765-2327
Email: support@byteme.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES