Home GUDID 08806195919804 DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
Primary DI 08806195919804
Brand DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
Company DIO Corporation
Model SSAP 4510S
Catalog number SSAP 4510S
Device description The DIO UF HSA Internal Sub-Merged Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surery. A successfully osseointegrated implant willl achieve a firm implant when the fixture is operated under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edendulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist of screws(Cover Screw, Coping Screw), abutments(Screw retained type, Cemented retained type, Over denture retained type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F67) and Ti-6A1-4VELI(ASTM F136) intended to be used in a narrow tooth gap after implant insertion. And the screw is used to protect exposed top of the implant or to attach the abutment to implant.
Published 2016-01-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NHA Abutment, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NHA Abutment, Implant, Dental, Endosseous Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08806195919804 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08806195919804 08806195919804 8806195919804
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 1 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 631085206 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840481138218 LOCATOR Fixed Zest Anchors, LLC NHA 2026-05-22 00840481138225 LOCATOR Fixed Zest Anchors, LLC NHA 2026-05-22 00840481138232 LOCATOR Fixed Zest Anchors, LLC NHA 2026-05-22 07290120481039 IH Straight Shoulder Abutment 3.75mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120481237 IH Straight Shoulder Abutment 3.75mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120481435 IH Straight Shoulder Abutment 3.75mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120482470 IH Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120482524 IH Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120482579 IH Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120482623 IH Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120482678 IH Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120486621 NP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120486676 NP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120486720 NP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120486775 NP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120486829 NP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120486874 RP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120486928 RP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120486973 RP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487024 RP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487079 RP Straight Multi-Unit Abutment SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487383 NP Straight Anatomic Abutment 3.0mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487437 RP Straight Anatomic Abutment 5.0mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487482 RP Straight Anatomic Abutment 5.0mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487529 IH Straight Curve Concave Abutment 3.75mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487536 NP Straight Anatomic Abutment 3.0mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487628 IH Straight Curve Concave Abutment 3.75mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487727 IH Straight Curve Concave Abutment 3.75mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120487826 IH Straight Curve Concave Abutment 3.75mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24 07290120488328 IH Straight Anatomic Abutment 3.75mm diameter SURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTD NHA 2026-03-24