AccessGUDID - DEVICE: Waterpik Key-To Alginate Impression Material (D6860131139)

GUDID

Device Identifier (DI) Information

Brand Name: Waterpik Key-To Alginate Impression Material
Version or Model: 013113-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 013113-000
Company Name: WATER PIK, INC.

Primary DI Number: D6860131139
Issuing Agency: HIBCC
Commercial Distribution End Date: September 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 001804074 *Terms of Use

Device Description: Regular Body, Fast Set

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
35863	Alginate dental impression material	A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELW	Material, Impression

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970594	000

Device Exempt from Premarket Submission: No 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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 1 Pound

Device Record Status

Public Device Record Key: cee7bb41-e07e-4634-9a3c-91ad106a839b
Public Version Date: September 16, 2025
Public Version Number: 5
DI Record Publish Date: August 02, 2016