AccessGUDID - DEVICE: Dycal® Ivory Radiopaque Calcium Hydroxide Composition (D0026237011)

GUDID

Device Identifier (DI) Information

Brand Name: Dycal® Ivory Radiopaque Calcium Hydroxide Composition
Version or Model: 623701
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 623701
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026237011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Dycal® Radiopaque Calcium Hydroxide Composition Tube Refill Package - Ivory Shade

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):	Yes
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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJK	LINER, CAVITY, CALCIUM HYDROXIDE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K780384	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
Special Storage Condition, Specify: Keep out of direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
Weight: 11 Gram
Weight: 13 Gram
Device Size Text, specify: 6 Base (13g each), 6 Catalyst (11g each), 4 Mixing Pads

Device Record Status

Public Device Record Key: 801789f1-d8de-4d33-bfe6-689c78d87460
Public Version Date: August 31, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016