AccessGUDID - DEVICE: ProSeal (D798PRO0)

GUDID

Device Identifier (DI) Information

Brand Name: ProSeal
Version or Model: PRO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRO
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798PRO0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: PRO SEAL® and LED PRO SEAL® are intended for use as an enamel surface sealant around orthodontic brackets. 6ml bottle ProSeal

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?
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
EBD	Coating, Filling Material, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021503	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: Store at room temperature (15-30 Degrees C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 21a06a9d-e546-4b21-9dfd-ab46e7596b55
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 15, 2016