AccessGUDID - DEVICE: SciPharm Luster Polishing Paste, Spanish (D801SP5005S1)

GUDID

Device Identifier (DI) Information

Brand Name: SciPharm Luster Polishing Paste, Spanish
Version or Model: SP 50-05 S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50-05
Company Name: SCIENTIFIC PHARMACEUTICALS, INC.

Primary DI Number: D801SP5005S1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096010525 *Terms of Use

Device Description: Dental Polishing Paste for Composite Restoratives, Amalgams, and Castings.

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?
11168	Dentifrice	A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJR	Agent, Polishing, Abrasive, Oral Cavity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K842403	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
Storage Environment Temperature: between 15 and 83 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6de16a3f-48a8-4820-ab68-7ec711d5688c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 08, 2016