(338 days)
No
The summary describes a physical dental implant system made of zirconia and PEEK, with no mention of software, algorithms, or data processing that would suggest AI/ML.
No.
The device is intended to provide support for prosthetic devices to restore aesthetics and chewing function, not for treating a disease or condition.
No
The Zeramex® P6 Dental Implant System is intended for the surgical placement of implants to support prosthetic devices, restoring aesthetics and chewing function, rather than for diagnosing conditions.
No
The device description clearly outlines physical components made of materials like zirconia and PEEK, including implants, abutments, screws, healing caps, and gingiva formers. This indicates a hardware-based medical device system, not a software-only one.
Based on the provided information, the Zeramex® P6 Dental Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices... in order to restore aesthetics and chewing function." This describes a device used in vivo (within the body) for structural support and functional restoration.
- Device Description: The description details implants, abutments, screws, and surgical tools used for placement and restoration within the patient's mouth. These are all components of a surgical implant system.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Zeramex® P6 system does not perform any such function. It is a physical implant placed within the body.
Therefore, the Zeramex® P6 Dental Implant System is a medical device, specifically a dental implant system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.
The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.
The Zeramex® P6 implants are intended for delayed loading.
The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.
The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.
Product codes
DZE, NHA
Device Description
The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.
The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm. 4.1 mm. and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected.
Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN: 4.0mm) and regular neck (RN. 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants.
The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions.
The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.
Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ.
The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185).
The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) PEEK-Optima™ Ultra (Endolign) screws (provided as straight and angular screws in SN and RN sizes).
Healing caps and gingiva formers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingiva formers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper and lower jaw, anterior teeth in the lower jaw and lateral teeth in the upper jaw
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, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies:
- Cleaning and Sterilization Validation according to ISO 17665-1, ISO 17665-2. ISO 11737-1 and ISO 11737-2.
- Shelf-life, Packaging, and transport validation according to ASTM F1980, ASTM F88. ASTM F1886. ASTM F1929, ISO 11607-1, and ISO 11607-2.
- Biocompatibility in accordance with ISO 10993-5
- Surface chemical and roughness analysis by XPS. SEM, and contact angle.
- Fatigue testing in accordance with ISO 14801 for new as well as artificially aged samples of the submission device
Clinical Studies:
Retrospective clinical data on implants and prosthetics was obtained on 19 patients who received a total of 35 screw retained abutments. Follow up data was obtained on 15 of those patients (representing 27 screw retained abutments), with > 6 month follow up data on eight (8) patients, and > 1 year follow up data on three (3) patients.
Patients were between the ages of 36 and 69 years old, with no local risk factors. Implants were placed in the maxilla and mandible using a 2-step loading process with the time to loading ranging from 12 to 24 weeks.
Bone quantity ranged very heavy bone to soft bone, with all patients presenting with good bone quality.
No post-operative complications or adverse events were reported for any of the patients at the implant placement and loading phases. Follow up data (n = 15 patients, 27 implants/abutments) shows that there were no post-operative complications defined as anesthesia or paresthesia, mandibular fracture, loss of alveolar ridge height, adverse impact on adjacent teeth, abnormal or prolonged pain, failure to maintain adequate oral hygiene, fistula, infection, or osteomyelitis. No adverse reactions (infection, pain, altered sensation, temporomandibular joint problems, implant loss prior to loading, loss of loaded implant, implant breakage, or abutment breakage) were reported. In addition, there were no reports of screw movement, fracture, or replacement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Zeramex® T Dental Implant System, Dentalpoint AG, K133255
Reference Device(s)
Branemark System Dental Implant Products, Nobel Biocare AB, K022562, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, LLC, K130222, Procera® Abutment Branemark, Nobel Biocare USA LLC, K042658
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2016
Dentalpoint AG % Roshana Ahmed, MA, RAC Senior Manager, Regulatory Affairs- Medical Devices Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K152385
Trade/Device Name: Zeramax® P6 Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 6, 2016 Received: June 7, 2016
Dear Roshana Ahmed:
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
1
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 yours,
Tina Kiang
-s
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
2
Indications for Use
510(k) Number (if known) K152385
Device Name Zeramex® P6 Dental Implant System
Indications for Use (Describe)
The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.
The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.
The Zeramex® P6 implants are intended for delayed loading.
The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.
The Zeramex® P6 (03.3mm SN) implant may only be used in the lower jaw and lateral teeth in the upper jaw.
| Type of Use (Select one or both, as applicable) | |
|---|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
I. Submitter
Dentalpoint AG Hohlstrasse 614 Zurich, Switzerland 8048
Phone: (+41) 44 388 36 36 Fax: (+41) 44 388 36 39
Contact Person: Viktor Lienhard, COO Date Prepared: July 25, 2016
II. Device
| Name of Device: | Zeramex® P6 Dental Implant System |
|---|---|
| Common or Usual Name: | Dental Implant System |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Regulatory Class: | II |
| Product Code: | DZE, NHA |
III.Predicate and Reference Devices
Substantial equivalence is claimed to the following predicate device:
-
Zeramex® T Dental Implant System, Dentalpoint AG, K133255 ●
The following devices are cited as reference devices: -
Branemark System Dental Implant Products, Nobel Biocare AB, K022562
-
. Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, LLC, K130222
-
Procera® Abutment Branemark, Nobel Biocare USA LLC, K042658
IV. Device Description
The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments
4
or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.
The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm. 4.1 mm. and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected.
Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN: 4.0mm) and regular neck (RN. 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants.
The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions.
The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.
Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ.
The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185).
The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) PEEK-Optima™ Ultra (Endolign) screws (provided as straight and angular screws in SN and RN sizes).
Healing caps and gingiva formers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingiva formers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support
5
temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.
V. Indications for Use
The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.
The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.
The Zeramex® P6 implants are intended for delayed loading.
The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.
The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.
VI. Comparison of Technological Characteristics
The Zeramex® P6 Dental Implant System and the predicate devices share the following characteristics:
- . Two-piece design
- . Abutments and implants have the same material of construction
- Cement retained abutments are fixed via an adhesive process which affixes the . abutment to the implant, in conjunction with the internal cylindrical connection (anti-rotation feature)
- . Screw retained abutments which fit on the implant's external hexagonal connection (anti-rotation feature)
- . The implants and abutments are provided in similar diameters and lengths as the predicate devices
- Abutments are provided in straight and angled (15°) configurations .
- Implant surfaces are treated via grit blasting and acid etching processes .
6
The Zeramex® P6 Dental Implant System is technologically different from the predicate devices as follows:
- . Provision of carbon-fiber reinforced PEEK screws for the screw retained abutments
A comparison of the subject and predicate devices is provided in the tables below.
Comparison of Dental Implants
| | Zeramex® P6
Dental Implant
System | Zeramex® T
Dental Implant
System
(K133255) | Straumann®
Dental Implant
System
(K130222) | Branemark
System Dental
Implant Products
(K022562) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use Statement | The Zeramex P6
Dental Implant
Systems is intended
to be surgically
placed in the bone of
the upper and lower
jaw to provide
support for prosthetic
devices, such as
artificial teeth, in
order to restore
aesthetics and
chewing function.
The Zeramex P6
Dental Implant
System can be used
for single or multiple
unit restorations. The
Zeramex P6 implants
are intended for
delayed loading. The
Zeramex P6 Dental
Implants are specially
indicated for patients
with metal
allergies/intolerances
and chronic illnesses
due to metal
allergies/intolerances.
The Zeramex P6
(Ø3.3) implant may
only be used in the
anterior teeth in the
lower jaw and lateral
teeth in the upper
jaw. | The Zeramex T
Dental Implant
Systems is intended
to be surgically
placed in the bone of
the upper and lower
jaw to provide
support for prosthetic
devices, such as
artificial teeth, in
order to restore
aesthetics and
chewing function.
The Zeramex T
Dental Implant
System can be used
for single or multiple
unit restorations. The
Zeramex T implants
are intended for
delayed loading. The
Zeramex T Dental
Implants are specially
indicated for patients
with metal allergies
and chronic illnesses
due to metal allergies.
The Zeramex T
(Ø3.5) implant may
only be used in the
anterior teeth in the
lower jaw and lateral
teeth in the upper
jaw. | Straumann dental
implants are indicated
for oral endosteal
implantation in the
upper and lwer jaw
arches for the
functional and
aesthetic oral
rehabilitation of
edentulous and
partially dentate
patients. Straumann
dental implants are
also indicated 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
occlusal loading to
restore chewing
function. The
prosthetic restoration
used are single
crowns, bridges and
partial or full
dentures, which are
connected to the
implants through the
corresponding
components
(abutments). | The Branemark
system implants are
for single stage or
two stage surgical
procedures and
cement or screw
retained restoration.
The Branemark
system implants are
intended for
immediate placement
and function on
single tooth and/or
multiple tooth
applications
recognizing sufficient
bone stability (type I
or ii bone) and
appropriate occlusal
loading, to restore
chewing function.
Multiple tooth
applicants may be
splinted with a bar. |
7
| Design | Two-piece design | Two-piece design | Two-piece design | Two-piece design |
|---|---|---|---|---|
| Implant | ||||
| Material | Zirconia | Zirconia | Grade 4 Titanium | Titanium |
| Implant | ||||
| Lengths | 8 mm | |||
| 10 mm | ||||
| 12 mm | 8 mm | |||
| 10 mm | ||||
| 12 mm | ||||
| 14 mm | 6 mm | |||
| 8 mm | ||||
| 10 mm | ||||
| 12 mm | ||||
| 14 mm | 7 mm | |||
| 8.5 mm | ||||
| 10 mm | ||||
| 11.5 mm | ||||
| 13 mm | ||||
| 15 mm | ||||
| 18 mm | ||||
| Implant | ||||
| Diameter | 3.3 mm | |||
| 4.1 mm | ||||
| 4.8 mm | 3.5 mm | |||
| 4.2 mm | ||||
| 5.5 mm | 3.3 mm | |||
| 4.1 mm | ||||
| 4.8 mm | 3.3 mm | |||
| 3.75 mm | ||||
| 4 mm | ||||
| 5 mm | ||||
| Implant | ||||
| Surface | ||||
| Treatment | Grit blasted, acid | |||
| etched | Grit blasted, acid | |||
| etched | Grit blasted, acid | |||
| etched - SLA or | ||||
| SLActive | Machined or | |||
| modified (TiUnite) | ||||
| Surface | ||||
| Anti-Rotation | ||||
| Features | Internal cylindrical | |||
| connection with | ||||
| internal triangular | ||||
| design (used for | ||||
| cemented | ||||
| abutments) and | ||||
| external hexagonal | ||||
| connections (used | ||||
| for screw retained | ||||
| abutments) | Internal cylindrical | |||
| connection with | ||||
| internal triangular | ||||
| design | Internal octagon | |||
| connection | Internal tri-channel | |||
| or external | ||||
| hexagonal | ||||
| connection | ||||
| Sterilization | Steam, SAL 10-6 | Steam, SAL 10-6 | Gamma | Gamma |
Comparison of Abutments
| | Zeramex® P6 Dental
Implant System | Zeramex® T Dental
Implant System
(K133255) | Procera® Abutment
Branemark
(K042658) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use Statement | The Zeramex P6 Dental
Implant Systems is intended
to be surgically placed in the
bone of the upper and lower
jaw to provide support for
prosthetic devices, such as
artificial teeth, in order to
restore aesthetics and
chewing function. The
Zeramex P6 Dental Implant
System can be used for
single or multiple unit
restorations. The Zeramex
P6 implants are intended for
delayed loading. The | The Zeramex T Dental
Implant Systems is
intended to be surgically
placed in the bone of the
upper and lower jaw to
provide support for
prosthetic devices, such as
artificial teeth, in order to
restore aesthetics and
chewing function. The
Zeramex T Dental Implant
System can be used for
single or multiple unit
restorations. The Zeramex
T implants are intended for | Nobel Biocare's Procera
Abutment Branemark is
indicated for the treatment of
partially edentulous patients
requiring a prosthetic device. In
addition to the Branemark
implant, the abutments' hexagon
connector fits the external
hexagon of the following
endosseous implants: 3i
3.75mm, Lifecore Biocmedical
Restore 3.75mm, Zimmer Dental
Taperlock 4.0mm, and Sterngold
Implamed 3.75mm. |
8
Dentalpoint AG K152385
| | Zeramex P6 Dental Implants
are specially indicated for
patients with metal
allergies/intolerances and
chronic illnesses due to
metal allergies/intolerances.
The Zeramex P6 (Ø3.3)
implant may only be used in
the anterior teeth in the
lower jaw and lateral teeth in
the upper jaw. | delayed loading. The
Zeramex T Dental Implants
are specially indicated for
patients with metal allergies
and chronic illnesses due to
metal allergies. The
Zeramex T (Ø3.5) implant
may only be used in the
anterior teeth in the lower
jaw and lateral teeth in the
upper jaw. | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Abutment
Material | Zirconia | Zirconia | Zirconia
Titanium
Alumina |
| Abutment
Angulation | Straight
Angled, 15° | Straight
Angled, 15° | Straight
Angled, 10° and 15° |
| Connection to
Implant | Cement Retained
(internal cylindrical
connection with
hexagonal design) &
Screw Retained
(external hexagon
connection) | Cement Retained
(internal cylindrical
connection with
hexagonal design) | -
Screw Retained
(external hexagon
connection) |
| Screw Material | Carbon-Fiber Reinforced
PEEK | N/A | Titan 6A17Nb (TAN) Screw |
| Sterilization | End User Sterilized | End User Sterilized | End User Sterilized |
Discussion
There is only a slight difference between the indications for use statement of the Zeramex® P6 Dental Implant System and the Zeramex® T Dental Implant System which is the addition of the term "intolerances". The addition of patients with metal intolerances to the previous indication for patients with metal allergies does not change the intended use of the device for patients for which traditional titanium implant systems may not be appropriate.
The ZERAMEX® P6 Implants feature the same material, same connection concept (internal cylinder with triangular anti-rotation feature), same surface treatment, and similar abutments as the previously cleared ZERAMEX® T system for cemented abutments.
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As seen above, the differences between the subject and primary predicate is the provision of screw retained abutments, addition of an external hexagon anti-rotation feature for the screw-retained abutments, the inclusion of a carbon-fiber reinforced PEEK abutment fixation screw, and the reduction of the implant body diameter from 3.5 to 3.3mm.
The implants are similar in shape and diameter as the previously cleared Straumann® Implants. The ZERAMEX® P6 Implants additionally feature an external hexagon connection similar to the previously cleared Branemark Implants.
The connecting abutment features a fitting hexagon and is of same material as the previously cleared Procera® Abutment.
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Studies
- . Cleaning and Sterilization Validation according to ISO 17665-1, ISO 17665-2. ISO 11737-1 and ISO 11737-2.
- Shelf-life, Packaging, and transport validation according to ASTM F1980, ASTM ● F88. ASTM F1886. ASTM F1929, ISO 11607-1, and ISO 11607-2.
- . Biocompatibility in accordance with ISO 10993-5
- Surface chemical and roughness analysis by XPS. SEM, and contact angle .
- . Fatigue testing in accordance with ISO 14801 for new as well as artificially aged samples of the submission device
Clinical Studies
Retrospective clinical data on implants and prosthetics was obtained on 19 patients who received a total of 35 screw retained abutments. Follow up data was obtained on 15 of those patients (representing 27 screw retained abutments), with > 6 month follow up data on eight (8) patients, and > 1 year follow up data on three (3) patients.
Patients were between the ages of 36 and 69 years old, with no local risk factors. Implants were placed in the maxilla and mandible using a 2-step loading process with the time to loading ranging from 12 to 24 weeks.
Bone quantity ranged very heavy bone to soft bone, with all patients presenting with good bone quality.
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No post-operative complications or adverse events were reported for any of the patients at the implant placement and loading phases. Follow up data (n = 15 patients, 27 implants/abutments) shows that there were no post-operative complications defined as anesthesia or paresthesia, mandibular fracture, loss of alveolar ridge height, adverse impact on adjacent teeth, abnormal or prolonged pain, failure to maintain adequate oral hygiene, fistula, infection, or osteomyelitis. No adverse reactions (infection, pain, altered sensation, temporomandibular joint problems, implant loss prior to loading, loss of loaded implant, implant breakage, or abutment breakage) were reported. In addition, there were no reports of screw movement, fracture, or replacement.
Conclusion
Although differences in design and technology exist between the subject and predicate devices, these differences are supported by the biocompatibility, fatigue, and retrospective clinical study data described above. Therefore, it is concluded that the Zeramex® P6 Dental Implant System is substantially equivalent to the predicate devices.