AccessGUDID - DEVICE: Bosworth Esteem (H66809215601)

GUDID

Device Identifier (DI) Information

Brand Name: Bosworth Esteem
Version or Model: 0921560
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0921560
Company Name: Harry J Bosworth Company

Primary DI Number: H66809215601
Issuing Agency: HIBCC
Commercial Distribution End Date: October 13, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 014769301 *Terms of Use

Device Description: Esteem Composite Standard Kit 14 g & 14 g

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:	Yes
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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Keep away from moisture
Storage Environment Temperature: between 2 and 10 Degrees Celsius
Storage Environment Temperature: between 35 and 50 Degrees Fahrenheit
Special Storage Condition, Specify: Keep out of direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Weight: 14 Gram

Device Record Status

Public Device Record Key: bbcf0daf-4aec-4255-af75-f0dfe3d95a9c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 15, 2016