AccessGUDID - DEVICE: SciPharm Seal and Bond Orthodontic (D801SP600241)

GUDID

Device Identifier (DI) Information

Brand Name: SciPharm Seal and Bond Orthodontic
Version or Model: SP 60-024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-024
Company Name: SCIENTIFIC PHARMACEUTICALS, INC.

Primary DI Number: D801SP600241
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 096010525 *Terms of Use

Device Description: Applied as an intermediate between enamel or dentin and as a restorative material or cement.

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?
42483	Dentine adhesive	A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DYH	Adhesive, Bracket And Tooth Conditioner, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K790962	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 73 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3e4a4f55-87dd-483b-9a18-3f75d7d6bf5c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 10, 2016