AccessGUDID - DEVICE: Quantum (D825200150009HA0)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum
Version or Model: 200-150-009 HA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200-150-009 HA
Company Name: QUANTUM BIOENGINEERING LTD.

Primary DI Number: D825200150009HA0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 797604456 *Terms of Use

Device Description: Thread Implant 5.0 X 9 HA

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
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
DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002241	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Millimeter
Length: 9 Millimeter

Device Record Status

Public Device Record Key: 21fd859e-4c1e-4411-ab08-124e75a1b199
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: April 12, 2018