What types of surface treatments does the Highness Implant System use to improve bone integration, and how might they benefit a patient?

The Highness Implant System features SLA (Sandblasted, Large-grit, Acid-etched) and superhydrophilic coatings on its implants. These treatments increase surface roughness and hydrophilicity, which enhance osseointegration—the process where bone grows directly onto the implant. This can lead to faster and more stable bone attachment, reducing healing time and improving long-term stability for prosthetic teeth.

Is the Highness Implant System intended for reuse, or is it designed for single-use only? How does this affect surgical workflow?

The Highness Implant System is sterile and single-use only, meaning each implant is intended for one surgical procedure. This design minimizes infection risks and ensures consistent performance, as reuse could compromise sterility and structural integrity. Clinicians must open a new sterile package for each implant placement, which aligns with best practices for dental implant surgery.

What storage conditions should be followed for the Highness Implant System to maintain its sterility and performance?

Since the Highness Implant System is sterile and single-use, it should be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Avoid storing it in areas with high humidity or chemical exposure, as these factors could degrade the implant’s integrity or compromise sterility.

How does the Highness Implant System’s regulatory approval impact its use in dental practices?

The Highness Implant System holds FDA 510(k) clearance (K240383) under the Traditional 510(k) pathway, with a Substantially Equivalent (SESE) determination by the Dental (DE) Advisory Committee. This means it meets FDA standards for safety and effectiveness as a dental implant device, allowing its use in U.S. dental offices and oral surgery clinics. Additionally, it complies with the MDD (Medical Device Directive) in relevant markets, ensuring it adheres to European biocompatibility and structural requirements.

Highness Implant System

by Highness Co., Ltd.

510(k) K240383Ref HSMN-Ⅰ3710, HS-Ⅶ6008, HSM-Ⅰ3008, SHA55102B, HS-Ⅶ7013, SCA4527-21, HS-Ⅰ4008, SAAH55325BF, SAAN65515B, HDB451010, SCA5544B, HS-Ⅰ7008, SHA45502-21B, HDLN40010M, HSMN-Ⅶ3715, HSN-Ⅰ5511, HSN-Ⅶ4507, HSN-Ⅰ5008, HS-Ⅶ6011, SAAH451015-21E, HSN-Ⅰ6013, HSN-Ⅶ7013, SAAH55525BF, SSA5527B, SAAH453015-21E, SHA65402B, HSN-Ⅰ6007, HSMN-Ⅰ3515, SSA5515B, SSA5524B, HSMN-Ⅶ3513, HS-Ⅰ3810, SAAH55515BF, SSA5514B, SMN5530, SSA4527B, HDB451015, SSA6554B, HSN-Ⅰ3815, SAAN45525B, SAAH65325BE, SSA4534B, HS-Ⅶ3813, HS-Ⅰ4510, HSN-Ⅶ3811, HS-Ⅶ5510, SMN5550, HSN-Ⅰ6008, HSN-Ⅶ4007, HS-Ⅰ4513Model SAAH55525BE

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240383↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-08800250904552 Basic UDI-DI	Date29 May 2026Registered	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK240383	Date31 Oct 2024Cleared	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Device Name: Dental Implant System
Model / Reference: HSMN-Ⅰ3710, HS-Ⅶ6008, HSM-Ⅰ3008, SHA55102B, HS-Ⅶ7013, SCA4527-21, HS-Ⅰ4008, SAAH55325BF, SAAN65515B, HDB451010, SCA5544B, HS-Ⅰ7008, SHA45502-21B, HDLN40010M, HSMN-Ⅶ3715, HSN-Ⅰ5511, HSN-Ⅶ4507, HSN-Ⅰ5008, HS-Ⅶ6011, SAAH451015-21E, HSN-Ⅰ6013, HSN-Ⅶ7013, SAAH55525BE, SAAH55525BF, SSA5527B, SAAH453015-21E, SHA65402B, HSN-Ⅰ6007, HSMN-Ⅰ3515, SSA5515B, SSA5524B, HSMN-Ⅶ3513, HS-Ⅰ3810, SAAH55515BF, SSA5514B, SMN5530, SSA4527B, HDB451015, SSA6554B, HSN-Ⅰ3815, SAAN45525B, SAAH65325BE, SSA4534B, HS-Ⅶ3813, HS-Ⅰ4510, HSN-Ⅶ3811, HS-Ⅶ5510, SMN5550, HSN-Ⅰ6008, HSN-Ⅶ4007, HS-Ⅰ4513

Primary DI / UDI-DI: 08800250904552, 08800108303469, 08800250907287, 08800108312096, 08809872389143, 08800108318807, 08800108306354, 08800108308709, 08800108309379, 08800108311068, 08800108306767, 08800108306057, 08809870726445, 08809872056854, 08800250905481, 08800250881273, 08800250883789, 08800250881198, 08800108303445, 08809872099370, 08800250881341, 08800250884069, 08800108308723, 08800108310344, 08809872099417, 08800108312263, 08800250881303, 08800250904538, 08800108310283, 08800108310245, 08800250905429, 08800108306408, 08800108308679, 08800108310238, 08800108309805, 08800108310047, 08800108310887, 08800108310573, 08800250881051, 08800108309027, 08800108308402, 08800108309959, 08800108303735, 08800108306286, 08800250883697, 08800108303513, 08800108309829, 08800250881310, 08800250883727, 08800108306262
Basic UDI-DI: B-08800250904552, B-08800108303469, B-08800250907287, B-08800108312096, B-08809872389143, B-08800108318807, B-08800108306354, B-08800108308709, B-08800108309379, B-08800108311068, B-08800108306767, B-08800108306057, B-08809870726445, B-08809872056854, B-08800250905481, B-08800250881273, B-08800250883789, B-08800250881198, B-08800108303445, B-08809872099370, B-08800250881341, B-08800250884069, B-08800108308723, B-08800108310344, B-08809872099417, B-08800108312263, B-08800250881303, B-08800250904538, B-08800108310283, B-08800108310245, B-08800250905429, B-08800108306408, B-08800108308679, B-08800108310238, B-08800108309805, B-08800108310047, B-08800108310887, B-08800108310573, B-08800250881051, B-08800108309027, B-08800108308402, B-08800108309959, B-08800108303735, B-08800108306286, B-08800250883697, B-08800108303513, B-08800108309829, B-08800250881310, B-08800250883727, B-08800108306262
510(k) Number: K240383
FDA Product Code: DZE
EMDN Code: P01020101 Dental implants

Device Class: Class IIb EUDAMED
Class II 510(k)
Regulation: 21 CFR Part 872.3640
EU market of registration: Germany
Advisory Committee: Dental
FDA Decision: SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	510(k)
Device Class	EUDAMED Class IIb	510(k) Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Highness Implant System is a dental implant device designed for osseointegration in the jawbone, facilitating the placement of prosthetic teeth. It incorporates surface treatments, including SLA and superhydrophilic coatings, to enhance bone integration and accelerate prosthetic loading.

This system is supplied as a sterile, single-use implant intended for surgical use in dental offices and oral surgery clinics. Authorized under FDA 510(k) clearance (K240383) and MDD compliance, it adheres to dental implant standards for biocompatibility and structural integrity. No additional regulatory status beyond the stated authorizations is implied.

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Questions

AI-generated answers, 18 Sep 2026