AccessGUDID - DEVICE: NuSmile NeoMTA (00862487000320)

GUDID

Device Identifier (DI) Information

Brand Name: NuSmile NeoMTA
Version or Model: NMTA 7.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: None
Company Name: NUSMILE, LTD.

Primary DI Number: 00862487000320
Issuing Agency: GS1
Commercial Distribution End Date: July 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 185497372 *Terms of Use

Device Description: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.

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:	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?
16704	Glass ionomer dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.	Active	false
36095	Endodontic filling/sealing material	A prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include (but are not limited to) silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). It does not include gutta-percha. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KIF	Resin, Root Canal Filling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140955	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: Moisture will reduce the shelf life of the powder
Special Storage Condition, Specify: Keep bottles tightly closed
Special Storage Condition, Specify: Do not refrigerate
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Weight: 7.0 Gram

Device Record Status

Public Device Record Key: 70f44890-0249-4f24-bc2a-822c6769d4e1
Public Version Date: June 25, 2021
Public Version Number: 4
DI Record Publish Date: February 15, 2017