AccessGUDID - DEVICE: 3.5 x 10 Simpler One Push in Implant HA (D780S150020)

GUDID

Device Identifier (DI) Information

Brand Name: 3.5 x 10 Simpler One Push in Implant HA
Version or Model: S1 5002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S1 5002
Company Name: Simpler Implant Solutions Inc

Primary DI Number: D780S150020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203213343 *Terms of Use

Device Description: 3.5mm Diameter x 10mm length Simpler One Surgery Two Piece Hydroxylapatite (HA) coated Push in implant

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

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
Device Size Text, specify: 3.25millimeters diameter x 10millimeters length

Device Record Status

Public Device Record Key: a0cce718-b06b-480c-bef4-d10fc6701330
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 24, 2015