AccessGUDID - DEVICE: SciPharm Pit & Fissure Sealer Bonding Agent (D801SP56011B1)

GUDID

Device Identifier (DI) Information

Brand Name: SciPharm Pit & Fissure Sealer Bonding Agent
Version or Model: SP 56-011 B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 56-011
Company Name: SCIENTIFIC PHARMACEUTICALS, INC.

Primary DI Number: D801SP56011B1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096010525 *Terms of Use

Device Description: Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched Enamel. White Opaque. Boxed.

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?
31780	Dental pit/fissure sealant	A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBC	Sealant, Pit And Fissure, And Conditioner

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K813091	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: less than 75 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41d97c3c-3426-470c-824f-4766fe0d5c4b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 09, 2016