(270 days)
No
The device description focuses on the physical components and materials of dental implant abutments, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are limited to bench testing for fatigue.
No.
The device is a prosthetic component that supports dental prosthetic reconstructions, not a device that directly treats a disease or condition.
No
The device description indicates that the Klockner Dental Implant Abutments are prosthetic components used for supporting dental restorations, not for diagnosing conditions or diseases.
No
The device description explicitly states that the abutments are made of titanium alloy, gold alloy, and Co-Cr-Mo alloy, indicating they are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic reconstructions in dental implants. This is a structural and mechanical function within the body.
- Device Description: The device description details physical components (abutments, caps) made of materials like titanium and gold alloy, designed for mechanical connection to dental implants.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies described are bench testing focused on fatigue, which is relevant to the mechanical integrity of the device, not its diagnostic accuracy.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a medical device used for prosthetic support in dental procedures.
N/A
Intended Use / Indications for Use
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutment, angled abutments, straight abutments, cast abutments. All abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Klockner Dental Implant Abutments (II) consist of a group of prosthetic components to be used with dental implants as an aid in prosthetic rehabilitation. According to their function, they are classified in:
- Protective cap, made of titanium alloy, intended to be provisionally connected to dental abutment as a protection when choosing direct oral impression on the abutment.
- Temporary abutment, made of titanium alloy, intended to be provisionally connected to dental abutment to retain a provisional screw-retained multiple-unit restoration.
- Angled abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations. These abutments, used when it is necessary to correct prosthesis axis with respect to implant axis, are available with different angulation and different transmucosal height, enabling the anatomic characterization of the gum margin and facilitating the prosthetic fitting.
- Straight abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations, with not correction of implant angulation. These abutments are available with different transmucosal height, enabling the anatomic characterization of the gum margin and facilitating the prosthetic fitting.
- Cast abutments, made of gold alloy and Co-Cr-Mo alloy, intended for cement-retained single- unit and multiple-unit restorations and for screw-retained single-unit restorations on dental implants using the casting technique.
All these abutments are designed for Klockner Dental Implant Systems, models Essential EC (K080224) and Essential EC 1.5 (K082200), with internal octagonal cone connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental implants
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 Data:
- Biocompatibility: All materials used have been subject to biological evaluation according to ISO 10993-1:2009 and ISO 7405:2008. Corrosion resistance and galvanic corrosion assays performed for Co-Cr cast abutments according to ISO 10993-15, ASTM F746 and ASTM G71, confirming high corrosion resistance and insignificant galvanic corrosion. Additional biocompatibility testing was not considered necessary as materials and manufacturing methods are identical to previously cleared devices.
- Sterilization: Subject to bioburden and sterility testing in accordance with ISO 11737-1 and ISO 11737-2, respectively. Steam sterilization validation performed according to ISO 17665-1.
- Bench testing: Fatigue testing conducted according to ISO 14801 and the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, considering worst-case conditions. Results show acceptable device performance as per intended use.
Clinical Data:
No clinical data are included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2016
SOADCO, S.L. Ms. Maria Mitjaneta Ouality Manager Avgda Fiter I Rosell., 4 Bis-local 2 Escaldes-Engordany, AD-700 ANDORRA
Re: K151194
Trade/Device Name: Klockner Dental Implant Abutments (II) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 16, 2015 Received: December 28, 2015
Dear Ms. Mitianeta:
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.
1
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 yours,
Tina Kiang -
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the logo for SOAD for KLOCKNER. The letters are large and gray, with the word "SOAD" in black. There is a globe image in the middle of the logo. The words "for KLOCKNER" are in a smaller font below the globe.
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Klockner Dental Implant Abutments (II)
Indications for Use:
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutment, angled abutments, straight abutments, cast abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.
V Prescription Use (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/1 description: The image shows the logo for SOAD for KLOCKNER. The logo is in black and white and features the letters "SOAD" in a stylized font. The letters are arranged in a slightly overlapping manner. The words "for KLOCKNER" are written in a smaller font below the letters "SOAD". There is a globe image in the middle of the logo.
510(k) SUMMARY K151194
Date of Preparation of Summary: January 25, 2016
| Submitter/owner name: | SOADCO, S.L. | ||
|---|---|---|---|
| Submitter/owner address: | Avgda. Fiter i Rossell, 4bis - Local 2 | ||
| ESCALDES - ENGORDANY | |||
| AD-700 (ANDORRA) | |||
| Contact person: | Maria Mitjaneta | ||
| Phone: | +376 800 590 | ||
| Fax: | +376 800 594 | ||
| e-mail: | calidad@soadco.com | ||
| Device Trade Name: | Klockner Dental Implant Abutments (II) | ||
| Common Name: | Dental Abutments | ||
| Classification Name: | Endosseous Dental Implant Abutments | ||
| Regulation Number: | 21 CFR 872.3630 | ||
| Class: | Class II | ||
| Panel: | Dental | ||
| Product code: | NHA |
Legally Marketed (Predicate) Device:
| PREDICATE DEVICE
| 510(k) Number | Device Trade Name | Manufacturer |
|---|---|---|
| K122988 | Klockner Dental Implant Abutments | SOADCO S.L. |
Device Description:
Klockner Dental Implant Abutments (II) consist of a group of prosthetic components to be used with dental implants as an aid in prosthetic rehabilitation. According to their function, they are classified in:
- -Protective cap, made of titanium alloy, intended to be provisionally connected to dental abutment as a protection when choosing direct oral impression on the abutment.
- ı Temporary abutment, made of titanium alloy, intended to be provisionally connected to dental abutment to retain a provisional screw-retained multiple-unit restoration.
- Angled abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations. These abutments, used when it is necessary to correct prosthesis axis with respect to implant axis, are available with different angulation and different transmucosal height, enabling the anatomic characterization of the gum margin and facilitating the prosthetic fitting.
4
Image /page/4/Picture/1 description: The image shows a logo for SOAD for KLOCKNER. The logo is in black and white and features the letters "SOAD" in a stylized font. The letter "O" is replaced by a globe. Below the letters "SOAD" is the text "for KLOCKNER" in a smaller font. The logo is likely for a company or organization called SOAD that is associated with KLOCKNER.
- Straight abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations, with not correction of implant angulation. These abutments are available with different transmucosal height, enabling the anatomic characterization of the qum margin and facilitating the prosthetic fitting.
- Cast abutments, made of gold alloy and Co-Cr-Mo alloy, intended for cement-retained single- unit and multiple-unit restorations and for screw-retained single-unit restorations on dental implants using the casting technique.
All these abutments are designed for Klockner Dental Implant Systems, models Essential EC (K080224) and Essential EC 1.5 (K082200), with internal octagonal cone connection.
Indications for Use:
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutments, straight abutments, cast abutments. All abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.
Summary of Comparison with Predicate Device:
In the establishment of substantial equivalence, Klockner Dental Implant Abutments (II) are compared to a legally marketed device with the same intended use.
Proposed device intended use, indications for use and technological characteristics have been compared with those of predicate device (see next pages), following the guidelines set out in guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Features of proposed device not shared with predicate device have been substantiated using two reference devices. These differences are not considered to raise different questions of safety and effectiveness than the predicate.
All issues affecting performance have been reviewed and discussed. Any differences have been addressed in the bench testing performed on the proposed device.
| REFERENCE DEVICE
| 510(k) Number | Device Trade Name | Manufacturer |
|---|---|---|
| K080224 | Klockner Essential Dental Implant System | SOADCO S.L. |
| K121843 | NP-Cast Abutment System | OSSTEM Implant Co., Ltd. |
- NOTE: Numbers noted as 'ref. xx xx xx' (where x means a number) in the table below refer to specific catalog numbers of devices in the Klockner Implant System.
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Image /page/5/Picture/1 description: The image shows the logo for SOADC for Klockner. The logo is in gray and features the letters "SOADC" in a stylized font. The "O" in "SOADC" contains a globe graphic. Below the "C" is the text "for KLOCKNER" in a smaller font.
| Features | PROPOSED DEVICE:
Klockner Dental Implant Abutments (II) | PREDICATE DEVICE K122988
(Klockner Dental Implant Abutments) | REFERENCE DEVICE K080224
(Essential Implant System) | REFERENCE DEVICE
K121843
(NP-Cast Abutment System) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The Klockner Dental Implant Abutments are
intended to be placed into dental implants to
provide support for prosthetic reconstructions
such as crowns, bridges. The Klockner Dental
Implant Abutments include protective cap,
temporary abutment, angled abutments, straight
abutments, cast abutments. All abutments are
intended to be used with the Klockner Dental
Implant Systems, models: Essential EC, Essential
EC 1.5. | The Klockner Dental Implant Abutments are
intended to be placed into dental implants to
provide support for prosthetic reconstructions
such as crowns, bridges or overdentures. The
Klockner Dental Implant Abutments include
healing caps, protective caps, temporary
abutments, angled abutments, straight
abutments, and overdentures. All abutments
are intended to be used with the Klockner
Dental Implant Systems, models: Essential
EC, Essential ES, Essential ECK, Essential
EC 1.5, SK2 and NK2. | The Klockner Essential implant system is
especially designed for surgical insertion into
the bone using additional material to replace
the root of the teeth, acting as the support for
the dental implants formed by implant
accessories.
The Essential Solid implants are fitted with an
internal octagonal conical connection
combined with an external octagonal
connection measuring 1.2 mm in height.
The Essential Cone implants are fitted with an
internal octagonal conical connection.
The Essential ECK implants are fitted with a
larger internal octagonal conical connection
than that of the Essential Cone implants.
Immediate loading is appropriate for the
Essential Solid, Essential Cone and Essential
ECK implants when good primary stability is
achieved with appropriate occlusal loading.
Abutments can be used in single tooth
replacements and multiple tooth restorations.
8mm Implants are not indicated for use as
unitary implants and for immediate load. | NP-Cast Abutment System is
intended for use with a dental
implant to provide support for
prosthetic restorations such as
crowns, bridges, or overdentures. |
| Design -
Protective
сар | EC multi-cone protective cap (ref. 10 05 16)
Protective cap intended to be provisionally
connected (contact ≤ 6 months) to 30º and 17º
angular Octacone® multi-cone abutments (ref. 10
10 37, 10 10 38, 10 10 43, 10 10 44, 10 10 45)
included in this submission, and also to 30º
anqular abutment multi-cone [occlusal screw] (ref
10 10 36) cleared in K122988, in order to cover
and protect their inner configuration when
choosing direct oral impression on these
abutments. | Proposed device has the same intended use
and is functionally equivalent to these
predicate devices:
EC 12º protective cap (ref. 10 05 14)
EC 250 protective cap (ref. 10 05 15)
These devices are also connected to dental
abutments in order to cover and protect their
inner configuration when performing direct
oral impression on them. | N/A | N/A |
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Image /page/6/Picture/1 description: The image shows the logo for SOAD for KLOCKNER. The logo is in black and white, and the letters are large and bold. The letter "O" in SOAD has a globe in the middle of it. The words "for KLOCKNER" are in a smaller font below the letter "O".
| Features | PROPOSED DEVICE:
Klockner Dental Implant Abutments (II) | PREDICATE DEVICE K122988
(Klockner Dental Implant Abutments) | REFERENCE DEVICE K080224
(Essential Implant System) | REFERENCE DEVICE
K121843
(NP-Cast Abutment System) |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Design -
Temporary
abutment | Circular Ti fitting - EC multi-cone (ref. 10 13 16)
Abutment intended to be provisionally connected
(contact ≤ 6 months) to 30° and 17° angular
Octacone® multi-cone abutments (ref. 10 10 37,
10 10 38, 10 10 43, 10 10 44, 10 10 45) included
in this submission, and also to 30° angular
abutment multi-cone [occlusal screw] (ref. 10 10
36) cleared in K122988, for retaining a provisional
screw-retained multiple-unit restoration while
definitive prosthesis is manufactured. | Proposed device has the same intended use
and is functionally equivalent to this predicate
device:
Circular Ti Fitting - EC 25° (ref. 10 13 15)
This device is also provisionally connected to
dental abutment to retain a provisional screw-
retained multiple-unit restoration while
definitive prosthesis is manufactured. | N/A | N/A |
| Design -
Cast
abutments | Abutments intended for cement-retained single-
unit and multiple-unit restorations and for screw-
retained single-unit restorations on Essential
Cone dental implants, using casting technique.
The design consists on a metal-based part with a
casting part over-injected in plastic (burned-out in
casting process):
- G Gold Octacone® abutment (ref. 10 10 13 G):
gold cast abutment intended to be connected to
wide platform Essential Cone implants. - Co-Cr Octacone® abutment (ref. 10 10 16): Co-
Cr cast abutment intended to be connected to
regular platform Essential Cone implants. - G Co-Cr Octacone® abutment (ref. 10 10 16 G):
Co-Cr cast abutment intended to be connected
to wide platform Essential Cone Implants. | N/A | Proposed devices have the same intended
use and are functionally equivalent to
reference device: - Gold Octacone® Abutment (ref. 10 10 13):
connected to regular platform Essential
Cone implants.
This abutment is also intended for cement-
retained single-unit and multiple-unit
restorations and for screw-retained single-unit
restorations on Essential Cone dental
implants, using casting technique.
The design also consists on a metal-based
part with a casting part over-injected in plastic
(burned-out in casting process). | N/A |
7
Image /page/7/Picture/1 description: The image shows the logo for SOADC for Klockner. The logo is in black and white, and the letters are large and bold. The letter "C" in SOADC has a globe inside of it. The words "for Klockner" are in a smaller font size and are located below the "C".
| Features | PROPOSED DEVICE:
Klockner Dental Implant Abutments (II) | PREDICATE DEVICE K122988
(Klockner Dental Implant Abutments) | REFERENCE DEVICE K080224
(Essential Implant System) | REFERENCE DEVICE
K121843
(NP-Cast Abutment System) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------|
| Design -
Straight
abutments | Straight abutments intended to be connected to
Essential Cone dental implants (regular platform)
for screw-retained multiple-unit restorations, with
not correction of implant angulation.
Designed with top conical shape (25° respect to
the implant axis) to make easier the placement of
the multiple-unit restoration, allowing the
correction of possible divergences among the axis
of the implants involved.
Available with different height from implant
platform and different transmucosal height (TH)
for enabling the anatomic characterization of the
gum margin and facilitating the prosthetic fitting:
- 25° Pillar abutment - [2.5 MM] - [TH 1 MM] (ref.
10 10 40) - 25° Pillar abutment - [4 MM] - [TH 2.5 MM] (ref.
10 10 41) - 25° Pillar abutment - [5.5 MM] - [TH 4 MM] (ref.
10 10 42) | Proposed devices have the same intended
use and are functionally equivalent to
predicate device: - 25° pillar abutment - 1mm (ref. 10 10 15)
This abutment is also intended to be
connected to Essential Cone dental implants
for screw-retained multiple-unit restorations,
with not correction of implant angulation.
It is designed with the same top conical shape
(25° respect to the implant axis) as that of
proposed devices, with 1 mm of height from
implant platform and without transmucosal
height (TH = 0). | N/A | N/A |
| Design -
Angled
abutments | Abutments with angulation that modifies the
prosthesis axis respect to the implant axis.
Intended to be connected to Essential Cone
dental implants (regular platform) for screw-
retained multiple-unit restorations.
Available with different angulation (30° and 17°)
and different transmucosal height (TH)1 for
enabling the anatomic characterization of the gum
margin and facilitating the prosthetic fitting: - 30° angular Octacone® multi-cone abutment
[TH 4 mm] (ref. 10 10 37) - 30° angular Octacone® multi-cone abutment
[TH 5 mm] (ref. 10 10 38) - 17° angular Octacone® multi-cone abutment
[TH 2 mm] (ref. 10 10 43) - 17° angular Octacone® multi-cone abutment
[TH 3 mm] (ref. 10 10 44) - 17° angular Octacone® multi-cone abutment
[TH 4 mm] (ref. 10 10 45) | Proposed devices have the same intended
use and are functionally equivalent to
predicate device: - 30° angular abutment multi-cone [occlusal
screw] (ref. 10 10 36)
This abutment is also intended to be
connected to Essential Cone dental implants
and be used for screw-retained multiple-unit
restorations.
It is designed with 30° angulation that modifies
the prosthesis axis respect to the implant axis,
and with transmucosal height (TH)1 of 3 mm. | N/A | N/A |
් Transmucosal height (TH) is the distance between implant-abutment connection] and prosthetic platform [abutment-prosthesis connection].
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Image /page/8/Picture/1 description: The image is a logo for SOADC for KLOCKNER. The logo is in black and white and features the letters "SOADC" in a stylized font. The "C" in SOADC is a globe. Below the letters is the text "for KLOCKNER" in a smaller font.
| Features | PROPOSED DEVICE:
Klockner Dental Implant Abutments (II) | PREDICATE DEVICE K122988
(Klockner Dental Implant Abutments) | REFERENCE DEVICE K080224
(Essential Implant System) | REFERENCE DEVICE
K121843
(NP-Cast Abutment System) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Material /
Composition | - Titanium alloy (ASTM F136, ISO 5832-3): used
in protective cap, temporary abutment, straight
abutments and angled abutments.
- Gold alloy 6019: used in gold cast abutment.
- Co-Cr-Mo alloy (ASTM F1537 alloy 1, ASTM
F799, ISO 5832-12): used in Co-Cr cast
abutments. - POM C: used in casting part of cast abutments
(material not intended to be in contact with the
patient, since it is burned-out during the casting
process of the abutments). | - Titanium alloy (ASTM F136, ISO 5832-3):
used in protective caps, temporary abutment
and straight abutment. | - Gold alloy 6019: used in Gold Octacone®
Abutment. - POM C: used in casting part of Gold
Octacone® Abutment. | - Co-Cr-Mo alloy: used in NP-
Cast Abutment System. |
| Sterility | All devices (protective cap, temporary abutment,
cast abutments, straight abutments and angled
abutments) are provided non-sterile.
These devices are individually packed and
provided non-sterile, but intended to be sterilized
before placement in the mouth. Instructions for
use contain the recommended sterilization
process validated as per standard ISO 17665-1. | Predicate devices (protective caps, temporary
abutment, straight abutment and angled
abutment) are also provided non-sterile.
As proposed devices, these predicates are
individually packed and provided non-sterile,
but intended to be sterilized before placement
in the mouth. The same sterilization process
(validated as per ISO 17665-1) is
recommended. | Reference device (cast abutment) is also
provided non-sterile.
As proposed devices, this reference device is
individually packed and provided non-sterile,
but intended to be sterilized before placement
in the mouth. The same sterilization process
(validated as per ISO 17665-1) is
recommended. | N/A |
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Image /page/9/Picture/1 description: The image shows the logo for SOADC for KLOCKNER. The letters SOAD are in black, and the letters C and D are in white with a black outline. The words "for KLOCKNER" are in a smaller font size and are located below the letters C and D. The background of the logo is gray.
Summary Discussion of Non-Clinical Data:
- Biocompatibility .
All materials used in the manufacture of Klockner Dental Implant Abutments (II) have been subject to biological evaluation taking account the intended use of the devices and the nature and duration of contact with the patient, according to the requirements of applicable recognized standards ISO 10993-1:2009 and ISO 7405:2008. In the case of Co-Cr cast abutments, the potential degradation of the material in biological environments has also been contemplated; corrosion resistance and galvanic corrosion assays have been carried out according to ISO 10993-15, ASTM F746 and ASTM G71, and test results confirm the high corrosion resistance of Co-Cr-Mo alloy and show an insignificant galvanic corrosion of this material with respect to unalloyed titanium (Ti c.p.) and titanium alloy (Ti-6Al-4V). The materials and manufacturing methods used for the subject device are identical to those
used in the previously cleared devices, and so additional biocompatibility testing was not considered to be necessary to support the substantial equivalence of the subject device.
-
Sterilization .
Klockner Dental Implant Abutments (II) have been subject to bioburden and sterility testing in accordance with ISO 11737-1 and ISO 11737-2, respectively. Steam sterilization validation according to ISO 17665-1 has been carried out to confirm the sterilization parameters. -
. Bench testing
Fatigue testing, conducted according to ISO 14801 and the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, has been performed considering worst-case conditions. Results obtained show that devices performance is acceptable as per their intended use.
Summary Discussion of Clinical Data:
No clinical data are included in this submission.
Conclusions:
We consider that the intended use, the operation principle and the technological characteristics of Klockner Dental Implant Abutments (II) are equivalent to those of predicate devices, although there is a slight difference in the indications for use statement of the subject device compared to the predicate with respect to implant compatibility. There are minor technological differences between the subject and predicate devices. The results of bench testing support the conclusion that risks associated with these technological changes have been adequately mitigated.
Therefore, substantial equivalence of Klockner Dental Implant Abutments (II) to the predicate devices may be established.