AccessGUDID - DEVICE: Harvard MTA XR Flow EWT OptiCaps (EHAR70815041)

GUDID

Device Identifier (DI) Information

Brand Name: Harvard MTA XR Flow EWT OptiCaps
Version or Model: 7081504
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Harvard Dental International GmbH

Primary DI Number: EHAR70815041
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 341553293 *Terms of Use

Device Description: Endodontic repair cement, flowable, with extended working time

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?
60510	Hygroscopic dental cement	A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KIF	Resin, Root Canal Filling

FDA Premarket Submission

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

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 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac0157bf-1446-43d7-85bb-352247905731
Public Version Date: December 08, 2021
Public Version Number: 3
DI Record Publish Date: September 15, 2016