AccessGUDID - DEVICE: Titanium screw M 1.4 x 3.5 mm (EBRE3300K7100)

GUDID

Device Identifier (DI) Information

Brand Name: Titanium screw M 1.4 x 3.5 mm
Version or Model: 3300K710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3300K710
Company Name: bredent GmbH & Co. KG

Primary DI Number: EBRE3300K7100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 341086190 *Terms of Use

Device Description: Titanium screw M 1.4 x 3.5 mm 10 Pieces

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):	No
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?
55849	Screw endosteal dental implant, two-piece	A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
EBL	PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 5.5 Millimeter
Outer Diameter: 2.3 Millimeter

Device Record Status

Public Device Record Key: 764cd37d-aa8f-49ca-b5b6-fc7f32f7d5b2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 2016