DAPDISH

Basic Information

• Brand Name: DAPDISH
• Primary DI: D832901DD11
• Version / Model: 901DD-1
• Catalog Number: 901DD-1
• Company Name: PLASDENT CORPORATION
• Labeler DUNS: 190377184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2022-01-14
• Public Version: 1
• Public Version Date: 2022-01-24
• Public Version Status: New
• Public Device Record Key: f5019184-4edd-45dc-b644-74c3aa013f2a

Device Description

Dappen Dishes, White

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45120	Dappen dish, single-use	A small, shallow concave vessel made of a thermoplastic material used to mix dental materials chairside prior to application to the patient during dental procedures. The device is typically placed in a holder while the user dispenses the required amount of component materials into it and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. The device will then be placed in a hand-held holder for patient application. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D832901DDB11	HIBCC	Box	1000	In Commercial Distribution
Primary	D832901DD11	HIBCC
Unit of Use	D832901DD10	HIBCC