AccessGUDID - DEVICE: Dentalis (04560128312592)

GUDID

Device Identifier (DI) Information

Brand Name: Dentalis
Version or Model: Powder
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.

Primary DI Number: 04560128312592
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 691229181 *Terms of Use

Device Description: Endodontic sealing material, 15g Powder

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:	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?
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
EMA	Cement, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971642	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: Avoid exposure to direct sunlight.
Storage Environment Temperature: between 1 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9c5cbc2c-4377-41af-a1c3-eb46d61aae47
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 14, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 253-946-0814
Email: karin@neodental-intl.com

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