AccessGUDID - DEVICE: Prima Titanium Implant 3.75mmd/10mml (07290112760043)

GUDID

Device Identifier (DI) Information

Brand Name: Prima Titanium Implant 3.75mmd/10mml
Version or Model: A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 111037
Company Name: DMI INNOVATIVE MEDICAL TECHNOLOGY LTD

Primary DI Number: 07290112760043
Issuing Agency: GS1
Commercial Distribution End Date: January 12, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 649187788 *Terms of Use

Device Description: "PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."

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 [?]
K160060	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3.75 Millimeter
Length: 10 Millimeter
Device Size Text, specify: H2.43

Device Record Status

Public Device Record Key: 5b12a93f-0f86-4036-8c2c-8fd128d74b47
Public Version Date: January 20, 2023
Public Version Number: 1
DI Record Publish Date: January 12, 2023