(296 days)
No
The device description and performance studies focus on the material properties, mechanical strength, and sterilization of a temporary dental abutment. There is no mention of any software, algorithms, image processing, or data analysis that would suggest the use of AI or ML. The customization is described as manual ("hand-milling").
Yes
This device is a therapeutic device because its intended use is to provide temporary support for a prosthesis structure and to maintain, stabilize, and shape soft tissue during the healing phase, which are therapeutic functions.
No
Explanation: The device is a "temporary intermediary prosthetic component" used to support provisional prostheses and maintain soft tissue during healing. It does not identify or characterize a disease, injury, or condition.
No
The device description clearly describes a physical medical device made of PEEK and titanium alloy, intended for temporary support of dental prostheses. It involves mechanical components and physical customization.
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 temporary support for a prosthesis structure on dental implants. This is a therapeutic or restorative function, not a diagnostic one.
- Device Description: The device is a physical component (an abutment) designed to be implanted and support a prosthesis. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing information for diagnosis.
- Anatomical Site: The device is used on the bone of the jaw, which is a direct interaction with the patient's body, not an in vitro analysis.
In vitro diagnostics (IVDs) are devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures.
This device clearly falls outside of this definition. It is a medical device used in a surgical and prosthetic procedure.
N/A
Intended Use / Indications for Use
The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.
Product codes
NHA
Device Description
CM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto CM Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body with an internal channel for the screw access and of a base for anti-rotational implant connection. The customizable portion is manufactured in PEEK (high performance polymer – specific for dental use) and the implant-to-abutment interface is made of titanium alloy. They have a coupled screw for fixing them to the Implant.
They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant.
They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm.
The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification.
The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Biocompatibility testing:
The raw material PEEK used in fabrication of the CM Pro PEEK Abutments is the same of that cleared for the predicate device under K093027. Any difference in the biocompatibility posed by differences in the manufacturing process has been addressed by chemical characterization and cytotoxicity assessments. No extracts of leachable substances of concern were identified and no cytotoxicity response was observed.
The Biological Assessment has been performed according to ISO 10993-1 Biological evaluation of medical devices. Evaluation and testing, ISO 10993-5 Biological evaluation of medical devices. Tests for in vitro cytotoxicity and ISO 10993-18 Biological evaluation of medical devices. Chemical characterization of materials.
Mechanical testing:
The strength of the CM Pro PEEK Abutment is demonstrated through fatigue testing performed according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
Sterilization validation:
The subject abutments are sterilized by exposure to ethylene oxide (EO). Sterilization has been validated by the bioburden method, according to ISO 11135 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices. EO sterilization residuals have been verified to be less than the maximum allowable limits as defined in ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. All methods achieve a Sterility Assurance Level (SAL) of 10-6.
The subject devices are not represented to be non-pyrogenic.
Shelf life was determined through both real time and accelerated aging protocol, according to ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. After aging, samples were submitted to sterility test, thermal seal integrity test and tensile strength of thermal seal according to ISO 11737 - Sterilization of medical devices -Microbiological methods - Part 2: Tests of sterility Performed in the definition, validation and maintenance of a sterilization process and US Pharmacopeia; ASTM E499/E499M Standard Practice for Leaks Using the Mass Spectrometer Leak Detector in the Detector Probe Mode, ASTM F1929 Standard Test Method for detecting Seal Leaks in Porous Medical Packaging by Dye Penetration and ASTM F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials.
The sterile barrier shelf life for the subject devices is 2 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K093027 - Straumann RC Temporary Abutments, Institut Straumann AG
Reference Device(s)
K101945 - Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA, K133510 - Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
JJGC Industria e Comercio de Materiais Dentarios SA % Jennifer Jackson Senior Manager, Regulatory Affairs & Quality Management Straumann USA, LLC 60-100 Minuteman Rd Andover, Massachusetts 01810
November 2, 2017
Re: K170080
Trade/Device Name: Neodent Implant System - CM Pro PEEK Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 25, 2017 Received: September 26, 2017
Dear Jennifer Jackson:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Neodent Implant System - CM Pro PEEK Abutments
Indications for Use (Describe)
The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.
| 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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3
510(k) Summary
| Submitter | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315
Owner/Operator No.: 9005052 | | | | |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| | on behalf of: | | | | |
| | JJGC Indústria e Comércio de Materiais Dentários SA
Av. Juscelino Kubitschek de Olivera, 3291
Curtiba, Parana, BRAZIL 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 | | | | |
| Contact Person | Jennifer M. Jackson, MS
Director, Regulatory Affairs & Quality, Straumann USA
E-Mail: jennifer.jackson@straumann.com
Telephone (978) 747-2509 | | | | |
| Date Prepared | 02/November/2017 | | | | |
| Prepared by | Ana Carolina Martins Vianna
RA & Compliance Manager, Institut Straumann AG
ana.vianna@straumann.com | | | | |
| Product Code
Device Class
Classification Panel
Classification Name
Common Name
Proprietary name | NHA (21 CFR 872.3630)
II
Dental
Endosseous dental implant abutment (21 CFR 872.3630)
Endosseous dental implant abutment
Neodent Implant System - CM Pro PEEK Abutments | | | | |
| Primary Predicate
Devices
Reference Devices | K093027 - Straumann RC Temporary Abutments, Institut
Straumann AG
K101945 - Neodent Implant System, JJGC Indústria e Comércio de
Materiais Dentários SA
K133510 - Neodent Implant System, JJGC Indústria e Comércio de
Materiais Dentários SA | | | | |
4
5.1 Device Description
CM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto CM Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body with an internal channel for the screw access and of a base for anti-rotational implant connection. The customizable portion is manufactured in PEEK (high performance polymer – specific for dental use) and the implant-to-abutment interface is made of titanium alloy. They have a coupled screw for fixing them to the Implant.
They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant.
They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm.
Image /page/4/Picture/6 description: The image shows a dental implant abutment. The abutment is made of two parts: a white ceramic or composite material on top and a silver-colored metal base. The metal base has a threaded screw at the bottom for attachment to the implant fixture in the jawbone. The abutment is designed to connect the implant to a dental crown or other restoration.
Figure 1: Model of CM Pro PEEK abutment
The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification.
The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.
5
5.2 Indications for Use
The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.
5.3 Technological Characteristics
The temporary abutments made of PEEK are designed to be substantially equivalent to the predicate devices previously cleared per K093027.
The subject and predicate devices are based on the following same technological elements:
- Endosseous dental abutments to provide support for temporary restorations (primary predicate device);
- -Possibility of use in single or two-stage procedures, for single or multiple-unit restorations (reference devices);
- -Same sterilization methods and packaging (reference devices).
The following technological differences exist between the subject and predicate devices:
- Design of Morse taper implant-to-abutment interfaces; -
- -The subject abutment is provided sterile by EO exposition whereas its primary predicate device is provided non-sterile for end-user sterilization.
In the end of this Section, a comparison between the features of subject device and its predicate devices is shown in a tabular format. The assessment of the differences is also included.
5.4 Performance data
The following performance data supports the substantial equivalence determination:
Biocompatibility testing
The raw material PEEK used in fabrication of the CM Pro PEEK Abutments is the same of that cleared for the predicate device under K093027. Any difference in the biocompatibility posed by differences in the manufacturing process has been addressed by chemical characterization and cytotoxicity assessments. No extracts of leachable substances of concern were identified and no cytotoxicity response was observed.
The Biological Assessment has been performed according to ISO 10993-1 Biological evaluation of medical devices. Evaluation and testing, ISO 10993-5 Biological evaluation of medical devices. Tests for in vitro cytotoxicity and ISO 10993-18 Biological evaluation of medical devices. Chemical characterization of materials.
6
Mechanical testing
The strength of the CM Pro PEEK Abutment is demonstrated through fatigue testing performed according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
Sterilization validation
The subject abutments are sterilized by exposure to ethylene oxide (EO). Sterilization has been validated by the bioburden method, according to ISO 11135 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices. EO sterilization residuals have been verified to be less than the maximum allowable limits as defined in ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. All methods achieve a Sterility Assurance Level (SAL) of 10-6.
The subject devices are not represented to be non-pyrogenic.
Shelf life was determined through both real time and accelerated aging protocol, according to ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. After aging, samples were submitted to sterility test, thermal seal integrity test and tensile strength of thermal seal according to ISO 11737 - Sterilization of medical devices -Microbiological methods - Part 2: Tests of sterility Performed in the definition, validation and maintenance of a sterilization process and US Pharmacopeia; ASTM E499/E499M Standard Practice for Leaks Using the Mass Spectrometer Leak Detector in the Detector Probe Mode, ASTM F1929 Standard Test Method for detecting Seal Leaks in Porous Medical Packaging by Dye Penetration and ASTM F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials.
The sterile barrier shelf life for the subject devices is 2 years.
Clinical data
No clinical data has been submitted, referenced, or relied upon to demonstrate substantial equivalence.
7
Table 1: Comparison between the subject and predicate devices.
| | SUBJECT DEVICES | PRIMARY PREDICATE
DEVICES | REFERENCE DEVICES | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System -
CM Pro PEEK Abutment | Straumann RC Temporary
Abutment (K093027) | Neodent Implant System
(K101945) | Neodent Implant System
(K133510) | EQUIVALENCE DISCUSSION |
| Indications for
Use | The Pro PEEK Abutments are
indicated to be used on
Neodent implants to provide
temporary support for
prosthesis structure for up
to 6 months. They can be
used in one or two stage
procedures and also
immediate load when there
is good primary stability. | The Straumann RC
Temporary Abutments are
indicated for use in
Straumann RC Bone Level
Implants for temporary
restorations of single crowns
and bridges for up to six
months | The Neodent Implant
System is intended to be
surgically placed in the
bone of the upper or lower
jaw to provide support for
prosthetic devices such as
artificial teeth, to restore
chewing function. It may be
used with single-stage or
two-stage procedures, for
single or multiple unit
restorations, and may be
loaded immediately when
good primary stability is
achieved and with
appropriate occlusal
loading. Multiple tooth
applications may be rigidly
splinted. | The Neodent Implant
System is intended to be
surgically placed in the
bone of the upper or lower
jaw to provide support for
prosthetic devices such as
artificial teeth, to restore
chewing function. It may be
used with single-stage or
two-stage procedures, for
single or multiple unit
restorations, and may be
loaded immediately when
good primary stability is
achieved and with
appropriate occlusal
loading. Multiple tooth
applications may be rigidly
splinted | Equivalent
The Indications for Use for
the subject and primary
predicate devices are similar
with the exception of minor
wording differences.
The intention to provide
support to temporary
restorations is the same.
The subject device
Indications for Use
references the term
"prosthesis structure" which
is an overarching term that
encompasses both crowns
and bridges.
The specific indication for
immediate load when there
is good primary stability is
dependent on the implant
Indications for Use. The
implants also need to be
indicated for immediate
loading when good primary
stability is achieved. |
| | SUBJECT DEVICES | PRIMARY PREDICATE
DEVICES | REFERENCE DEVICES | | EQUIVALENCE DISCUSSION |
| | Neodent Implant System –
CM Pro PEEK Abutment | Straumann RC Temporary
Abutment (K093027) | Neodent Implant System
(K101945) | Neodent Implant System
(K133510) | |
| Platform
Diameter(s) | 4.5 and
6 mm | 4.5 mm | NA
(only permanent
abutments) | 3.3 mm
4.1/4.3 mm
5.0 mm | Equivalent
Subject device diameters are
the same of the predicate
devices or larger. Larger
diameters do not represent a
worst case in terms of
performance. |
| Material | Titanium alloy Ti-6Al-4V ELI
PEEK (polyetheretherketone) | Titanium alloy (Ti-6Al-7Nb,
TAN)
PEEK (polyetheretherketone) | Titanium Grade 4
Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Equivalent
The subject and the
predicate devices are made
of the same type of raw
material; the adequacy of the
systems have been
demonstrated via dynamic
fatigue tests and
biocompatibility assessment. |
| Implant-to-
Abutment
Connection | CM interface; 11.5° Morse
taper with anti-rotational
features. | Morse taper interface with
anti-rotational features | CM interface; 11.5° Morse
taper with anti-rotational
features. | HE (external hexagon)
interface | Equivalent
The performance of each
interface has been assessed
by dynamic fatigue testing. |
8
9
| | SUBJECT DEVICES | PRIMARY PREDICATE
DEVICES | REFERENCE DEVICES | | |
|---------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Neodent Implant System –
CM Pro PEEK Abutment | Straumann RC Temporary
Abutment (K093027) | Neodent Implant System
(K101945) | Neodent Implant System
(K133510) | EQUIVALENCE DISCUSSION |
| Compatibility | Compatible with Neodent
CM implants | Compatible with Straumann
implants | Compatible with Neodent
CM implants | Compatible with Neodent
HE implants | Equivalent
The interfaces of Neodent
and Straumann devices are
not interchangeable. Their
performances are assessed
respecting the fixtures
compatibility. |
| Sterility | Delivered sterile by EO
exposure. | Delivered non-sterile. To be
sterilized by user before
placed in patient mouth
(moist steam sterilization). | Delivered sterile by EO
exposure. | Delivered sterile by gamma
irradiation. | Equivalent
The sterilization method and
posterior handling of the
device is the same as the
reference devices. |
10
5.5 Conclusions
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices.