AccessGUDID - DEVICE: WR Premium Perfection Kit Led EU (E241WR0100)

GUDID

Device Identifier (DI) Information

Brand Name: WR Premium Perfection Kit Led EU
Version or Model: WR010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WR010
Company Name: Cavex Holland B.V.

Primary DI Number: E241WR0100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 419980156 *Terms of Use

Device Description: Dental Whitening Agent

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
Kit:	No
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?
38785	Dental bleaching agent	A dental liquid solution, paste or gel [e.g., containing hydrogen peroxide (H2O2)] intended to be used chairside by a healthcare professional to whiten teeth for therapeutic (e.g., restoration of traumatised tooth colour) or cosmetic purposes. It may be supplied as a prefilled applicator or mixing syringe; some types may include a desensitising agent (e.g., potassium nitrate). After application, this device cannot be reused.	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
Storage Environment Temperature: between 0 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 pcs

Device Record Status

Public Device Record Key: 8e93742d-02a2-4d3e-82c6-a4f6c9510ac2
Public Version Date: March 17, 2026
Public Version Number: 1
DI Record Publish Date: March 09, 2026

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +31(0)235307700
Email: r.woortman@cavex.nl

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