DIO Biotite-H Implant System

FDA UDI

Class II (US FDA UDI)

by DIO Corporation

Identity

Trade Name: DIO Biotite-H Implant System FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: 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+±- 5m thin bioactive layer of a calcium phosphate composite. Biotite -H Implant System composed of the two calciumphosphates brushite(>95% )and HA(<5%). FDA UDI
Model / Reference: SFN 3810H FDA UDI
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+±- 5m thin bioactive layer of a calcium phosphate composite. Biotite -H Implant System composed of the two calciumphosphates brushite(>95% )and HA(<5%). FDA UDI

Identifiers

Catalog Number: SFN 3810H FDA UDI
Primary DI / UDI-DI: 08806195922002 FDA UDI
510(k) Number: K073070 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

DIO Biotite-H Implant System by DIO Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K073070 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: DIO Corporation

Sources (1)

FDA UDI b1b48a39-dd1c-49e5-8534-7b3510be05f2 38 fields · synced Jun 8, 2026