AccessGUDID - DEVICE: DIO Biotite-H Implant System (08806195922071)

GUDID

Device Identifier (DI) Information

Brand Name: DIO Biotite-H Implant System
Version or Model: SFR 4508H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SFR 4508H
Company Name: DIO Corporation

Primary DI Number: 08806195922071
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631085206 *Terms of Use

Device Description: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIG BIOTITE -H Implant System is designed for conventional two-stage procedures for single and multiple unit prosthetics. The DIO Biotite-H Implant System's screw-form dental implant consist of machined titanium. Screw's Diameter: Φ3.8mm, Φ4.1mm, Φ4.5mm, Φ4.8mm, Φ5.3mm. Length: 8.0mm, 10.mm, 12.0mm, 14.0mm. The implant's raw material is titanium and its alloys for surgical implant applications (as perASTM-F-67, A-STM-F-136). The special implant surface is consists of 100% calcium phosphate(CaHPO 42H20). BioTite-H Implant System is an electrochemically deposited calcium phosphate coating based upon abiomimetic process in which implants are coated in an electrolytic bath with a 15+±- 5μm thin bioactive layer of a calcium phosphate composite. Biotite -H Implant System composed of the two calciumphosphates brushite(>95% )and HA(<5%).

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 [?]
K073070	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
Special Storage Condition, Specify: tmperature limitation 1˚C ~ 30˚C, Humidity 80%

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: ® Ø4.5X8mm

Device Record Status

Public Device Record Key: e8cb5334-3748-4af9-a93b-9a761b6f8f35
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 17, 2015