K Number

Device Name

Dental Implants OKTAGON Bone Level Tapered Design

Manufacturer

Hager& Meisinger GmbH

Date Cleared

2017-05-24

(114 days)

Product Code

DZE

Regulation Number

872.3640

Intended Use

The Dental Implants OKTAGON® Bone Level Tapered Design are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Device Description

The Dental Implants OKTAGON® Bone Level Tapered Design are an addition to the currently distributed Dental Implant System® OKTAGON Bone Level. The implants can be used for immediate or early implantation after loss or extraction of natural teeth. The endosteal implant body of the subject device has a conical shape in the coronal region and is cylindrical in the apical region. The apical cylindrical part of the implant is relevant for the given endosteal diameter of 3.3 to 4.1 mm. The implants are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is micro-structured in the endosted part and has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder is polished. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K143539, K140878

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical design, materials, and mechanical performance of the dental implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device (dental implant) supports prosthetic restorations but does not directly treat or cure a disease or condition.

Diagnostic

This device describes a dental implant, which is a prosthetic device for reconstructive purposes, not for diagnosing conditions or diseases.

SaMD (Software as a Medical Device)

The device description clearly describes a physical dental implant made of titanium, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is surgically placed in the body to provide support for prosthetic restorations. This is a direct medical intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a physical implant made of titanium, designed for surgical insertion into bone. This aligns with a surgical device, not a diagnostic one.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Dental Implants OKTAGON® Bone Level Tapered Design are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Product codes

DZE

Device Description

The endosteal implant body of the subject device has a conical shape in the coronal region and is cylindrical in the apical region. The apical cylindrical part of the implant is relevant for the given endosteal diameter of 3.3 to 4.1 mm. The implants are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is micro-structured in the endosted part and has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder is polished.

The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.

The submission contains the following tapered design implant variations:

BLT NC Ø 3.3 mm, L 8.0 mm BLT NC Ø 3.3 mm, L 10.0 mm BLT NC Ø 3.3 mm, L 12.0 mm

BLT NC Ø 3.75 mm, L 8.0 mm BLT NC Ø 3.75 mm, L 10.0 mm BLT NC Ø 3.75 mm, L 12.0 mm

BLT NC Ø 4.1 mm, L 8.0 mm BLT NC Ø 4.1 mm, L 10.0 mm BLT NC Ø 4.1 mm, L 12.0 mm

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary and/or mandibular arches

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Study Type: Fatigue Testing (breakage and fatigue tests)
Sample Size: Not specified.
Key Results: Conducted fulfilling the requirements of ISO 14801 and the FDA's "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments".

Key Metrics

Not Found

Predicate Device(s)

K143539, K140878

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Summary

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2017

Hager & Meisinger GmbH Melanie May Regulatory Affairs Hansemannstrasse 10 Neuss. 41468 GERMANY

Re: K170287

Trade/Device Name: Dental Implants OKTAGON® Bone Level Tapered Design Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: May 4, 2017 Received: May 8, 2017

Dear Melanie May:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Lori A. Wiggins -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K170287

Device Name

Dental Implants OKTAGON® Bone level Tapered Design

Indications for Use (Describe)

The Dental Implants OKTAGON® Bone Level Tapered Design are surgically placed in the maxillary and/or mandbular arches to provide support for prosthetic restorations in edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Dental Implants OKTAGON® Bone Level Tapered Design

510(k) Summary

1. Applicant's Name and Address

Hager & Meisinger GmbH
Hansemannstrasse 10
41468 Neuss
Germany
Phone: 0049 2131 2012 292
Fax: 0049 2131 2012 223
Contact Person: Dr. Melanie May
Regulatory Affairs

2. Date prepared

Date prepared:

05/23/2017

3. Name of the device

Trade Name:	Dental Implants OKTAGON® Bone level Tapered Design
Common Name:	Endosseous dental implants
Classification Name:	Endosseous dental implants
Product Code:	DZE
Regulation No:	872.3640
Class:	II
Panel:	Dental

4. Predicate Devices:

510(k) No.	Manufacturer	Trade Name
K143539	Hager & Meisinger GmbH	Dental Implant System OKTAGON® Bone Level
K140878	Straumann USA,LLC	Straumann® Bone Level Tapered Implants

5. Device Description:

Dental Implants OKTAGON® Bone Level Tapered Design

510(k) Summary

The submission contains the following tapered design implant variations:

BLT NC Ø 3.3 mm, L 8.0 mm BLT NC Ø 3.3 mm, L 10.0 mm BLT NC Ø 3.3 mm, L 12.0 mm

BLT NC Ø 3.75 mm, L 8.0 mm BLT NC Ø 3.75 mm, L 10.0 mm BLT NC Ø 3.75 mm, L 12.0 mm

BLT NC Ø 4.1 mm, L 8.0 mm BLT NC Ø 4.1 mm, L 10.0 mm BLT NC Ø 4.1 mm, L 12.0 mm

6. Indications for Use:

The Dental Implants OKTAGON® Bone Level Tapered Design are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

7. Performance tests and used standards

Information regarding biocompatibility testing, sterility validation and shelf life was leveraged from the predicate device KI43539.

The following standards have been followed for the development, production, performance and safety testing of the subject devices.

Fatigue Testing according to ISO 14801 ●
Evaluation of Biocompatibility according to ISO 10993-1, ISO 7405
Cytotoxicity Testing according to ISO 10993-5
Sterilization Validation for implants and accessories according to ISO I I I 37-1, ISO I I I I 37-2,

Dental Implants OKTAGON® Bone Level Tapered Design

510(k) Summary

Sterile Barrier Testing according to ASTM F88/F88M-09 and ASTM F1929-98 ●
Packaging of sterilized implants according to ISO I 1607-1
. Material Specification according to ASTM F67
Risk Management according to ISO I 497 I

In order to demonstrate substantial equivalence performance tests (breakage and fatigue tests) have been conducted fulfilling the requirements of ISO 14801 and the FDA's "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments".

8. Basis for substantial equivalence

The intended use for Dental Implant OKTAGON® Bone Level Tapered Design is identical to the named predicated devices. The implants have the same material composition and the same surface treatments. In addition, the implants are of the same, root-form design

Since the Dental Implants OKTAGON® Bone Level Tapered Design and the predicate implants have the same design, are made of the same materials (see table), exhibit the same performance characteristics (e.g. strength and function), and are furthermore intended for the same use, no new performance or safety issues are raised.

Manufacturer	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Straumann USA, LLC	Manufacturer	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Straumann USA, LLC
510(k) Number	unknown	K143539 (Primary Predicate Device)	K140878 (Reference Predicate Device)	Material	Titanium Grade 4	Titanium Grade 4	Titanium
Grade
4
Titanium-13Zirconium
alloy (Roxolid®)
Intended Use	The Dental Implants
OKTAGON® Bone Level
Tapered Design are surgically
placed in the maxillary and/or
mandibular arches to provide
support for prosthetic
restorations in edentulous or
partially edentulous patients.
The implants are intended to
be used with OKTAGON®
abutments and prosthetic
parts. The implants are
intended for delayed loading in
a two-stage surgery or for
immediate loading when good
primary stability is achieved
and with appropriate occlusal
load.	The implants are surgically
placed in the maxillary and/
or mandibular arches to
provide support for
prosthetic restorations in
edentulous or partially
edentulous patients. The
parts are intended to be
used with OKTAGON®
Bone Level abutments and
prosthetic parts. The
Dental Implant system
OKTAGON® Bone Level is
intended for delayed
loading, or for immediate
loading when good primary
stability is achieved and
with appropriate occlusal
load.	Straumann® dental
implants are indicated for
oral endosteal implantation
in the upper and lower jaw
and for the functional and
esthetic oral rehabilitation
of edentulous and partially
dentate patients.
Straumann dental implants
can also be used for
immediate or early
implantation following
extraction or loss of natural
teeth. Implants can be
placed with immediate
function on single-tooth
and/or multiple tooth
applications when good
primary stability is achieved
and with appropriate	Surface
endosseous	Micro-structured (grit blasted
and acid etched)	Micro-structured
(grit
blasted and acid etched)	SLA (grit blasted then acid
etched), SLA active
Manufacturer	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Straumann USA, LLC	Connection	Inner cone with octagonal
anti-rotation device	Inner cone with octagonal
anti-rotation device	Inner cone with octagonal
anti-rotation device
			occlusal loading, to restore
chewing function. The
prosthetic restorations used
are single crowns, bridges
and partial or full dentures,
which are connected to the
implants by the
corresponding elements
(abutments). In cases of
fully edentulous patients, 4
or more implants must be
used in immediately loaded
cases.	Length	8 to 12 mm	8 to 14mm	8 to 16 mm
Description	The endosteal implant body of
the subject device has a
conical shape in the coronal
region and is cylindrical in the
apical region. The apical
cylindrical part of the implant
is relevant for the given
endosteal diameter of 4.1
mm. The implants are made
of commercially pure Titanium
Grade 4 conforming to ASTM-
F67. The surface is micro-
structured in the endosteal
part and has been blasted
with high-grade corundum and
afterwards acid-etched. The
implant shoulder is polished.
The prosthetic connection is
achieved with the help of an
inner cone with an additional
octagonal anti-rotation device.
A sterile cover screw is
enclosed with the implant so
that an immediate occlusion
of the internal thread is
possible after successful
insertion.
Subject to this submission is a
tapered design implant
variation of 4.1 mm, which is
available in a range of
endosseous lengths.	The root-form designed
implant is made of
commercially pure Titanium
Grade 4 conforming to
ASTM Standard
Specification F67. The
surface is micro-structured
in the endosteal section and
the implant shoulder is
polished. The implant
surface has been blasted
with high-grade corundum
and afterwards acid-etched.
The prosthetic connection is
achieved with the help of an
inner cone with an
additional octagonal anti-
rotation device.
A sterile locking screw is
enclosed with the implant
so that an immediate
occlusion of the internal
thread is allowed after
successful insertion.
The endosseous dental
implants are available in a
range of endosseous
diameters and lengths.	The devices represent a line
extension of the previously
cleared Bone Level implants
of the Straumann Dental
Implant System (K062129,
K083550 and K121131).
The apical part of the
implants has a tapering
thread form and three
cutting flutes.
The implants are made of
Titanium Grade 4
respectively Titanium-
13Zirconium alloy
(Roxolid®). The surface
finishes are either SLA (grit
blasted then acid etched)
or SLAactive
The implant-to-abutment
connection (NC, RC) is
achieved by an inner cone
with octagonal anti-
rotation device.
The devices are available in
the endosseous diameters
3.3, 4.1 and 4.8 mm.	Endosseous
Diameter	3.3 to 4.1 mm	3.3 to 4.8 mm	3.3 to 4.8 mm

Dental Implants OKTAGON® Bone Level Tapered Design

510(k) Summary

Dental Implants OKTAGON® Bone Level Tapered Design

510(k) Summary

Based on these observations, we conclude that the Dental Implant OKTAGON® Bone Level Tapered Design are substantially equivalent to the legally marketed predicate devices described.