(209 days)
No
The document describes a ceramic dental implant and its physical characteristics and testing, with no mention of AI or ML.
No
This device is a dental implant used for restoration, it does not directly treat a disease or condition.
No
The provided text describes a dental implant used for restoration, not for diagnosing a condition.
No
The device description clearly states it is a physical implant made of ceramic and is part of an integrated system of endosseous dental implants with corresponding instruments and prosthetic parts. It also details physical characteristics like surface treatment and design.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the restoration of single tooth gaps and edentulous or partially edentulous jaws, with prosthetic restorations connected to the implants. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device is described as an endosseous dental implant, which is surgically placed into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a medical implant.
N/A
Intended Use / Indications for Use
The Straumann® PURE Ceramic Implant is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw.
The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Straumann® PURE Ceramic Implants (Tissue Level Monotype and Tissue Level two-piece design) are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding instruments and prosthetic parts. The Straumann® PURE Ceramic Implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched (ZLA® surface). The implants have a 1.8 mm high machined transmucosal neck. The Straumann® PURE Ceramic Implant has a two -piece design with internal connection based on features of the Straumann® Tissue Level Standard Plus and Straumann® Bone Level Implants. The Straumann® PURE Ceramic Implant Monotype features a monotype design where the ceramic abutment for final restoration is already built in.
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)
Nonclinical testing data submitted or referenced to demonstrate substantial equivalence in this 510(k) includes:
- Dynamic fatigue testing was conducted according to the FDA quidance document . "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants" and demonstrated the subject devices are equivalent to the primary predicate and reference devices. The test was conducted in saline (2 Hz and 37°C) at 2 million cycles.
- . Biological assessment was performed according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and to the FDA Guidance document Use of International Standard ISO 10993- 1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, (September 8, 2023). Cytotoxicity and chemical extraction tests were performed. No leachable substances were released in cytotoxic concentrations from the test item.
- K180477 & K171769 (Institut Straumann AG) referenced for sterilization validation in . accordance with ISO 11135, "Sterilization of health care products -- Ethylene oxide --Requirements for the development, validation and routine control of a sterilization process for medical devices," using the Half Cycle approach of the Overkill method. The subject devices are not represented to be "non-pyrogenic".
- K180477 & K171769 (Institut Straumann AG) referenced for the packaging stability . study and shelf-life study in accordance with ASTM F1980.
- The Straumann PURE Ceramic implants are non-magnetic and do not include an electrical . component. As such, the subject devices are not acted upon by the application of magnetic fields typical of Magnetic Resonance Imaging equipment. Therefore, the Straumann PURE Ceramic Implants do not raise concerns regarding electromagnetic compatibility and electrical safety, as the reference devices K180477 and K171769. However, the prosthetic components could be manufactured from metal material that can be affected by MRI environment. The MRI compatibility status must consider the clinically relevant construction, which may include assembly with metal devices that can be affected by MRI such as abutments and screws. Therefore, all devices are deemed to be MR Conditional.
- The ZLA® surface features a topography characterized by macro- and micro-roughness . of the subject devices and is identical to the reference devices cleared under K180477 and K171769.
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.
K171769 Straumann® PURE Ceramic Implants
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.
K180477 Straumann® PURE Ceramic Implants, K210336 - Neodent Implant System - Zirconia Implant System, K201491 Neodent Implant System Zirconia Implant System
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
§ 872.3640 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/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Institut Straumann AG % Jennifer Jackson Sr. Director Regulatory Affairs and Ouality Straumann USA, LLC 60 Minuteman Rd. Andover, Massachusetts 01810
December 10, 2024
Re: K241391
Trade/Device Name: Straumann® PURE Ceramic Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: May 15, 2024 Received: November 15, 2024
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241391
Device Name
Straumann® PURE Ceramic Implants
Indications for Use (Describe)
The Strauman® PURE Ceramic Implant is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw.
The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
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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4
Straumann® PURE Ceramic Implants
K241391 510(k) Summary
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | On the behalf of:
Institut Straumann AG
Peter Merian weg 12
4052 Basel, Switzerland |
| Contact Person: | Jennifer M. Jackson, MS
Sr.Director of Regulatory Affairs & Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By: | Corinne Arimatea
RA & Compliance Manager
Institut Straumann AG
Phone number: +41619651217 |
| Date Prepared: | December 09, 2024 |
Name of the Device
| Trade Names: | Straumann® PURE Ceramic Implants |
|---|---|
| Common Name: | Endosseous dental implant |
| Classification Name: | Endosseous dental implant |
| Regulation Number: | 21 CFR 872.3640 |
| Device Classification: | II |
| Product Code(s): | Primary product code - DZE |
5
Straumann® PURE Ceramic Implants
K241391 510(k) Summary
Predicate Device(s)
Primary Predicates:
-
K171769 Straumann® PURE Ceramic Implants .
Reference Devices: -
K180477 Straumann® PURE Ceramic Implants .
-
. K210336 - Neodent Implant System - Zirconia Implant System
-
K201491 Neodent Implant System Zirconia Implant System ●
Device Description
The Straumann® PURE Ceramic Implants (Tissue Level Monotype and Tissue Level two-piece design) are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding instruments and prosthetic parts. The Straumann® PURE Ceramic Implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched (ZLA® surface). The implants have a 1.8 mm high machined transmucosal neck. The Straumann® PURE Ceramic Implant has a two -piece design with internal connection based on features of the Straumann® Tissue Level Standard Plus and Straumann® Bone Level Implants. The Straumann® PURE Ceramic Implant Monotype features a monotype design where the ceramic abutment for final restoration is already built in.
Indications for Use
The Straumann® PURE Ceramic Implant is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw.
The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
6
Straumann® PURE Ceramic Implants
K241391 510(k) Summary
Technological Characteristics
The indications for use and technological characteristics of the subject devices are consistent with those of the primary predicate and reference devices as detailed in the following table.
7
Straumann® PURE Ceramic Implants
K241391 510(k) Summary
Table 1. Comparative Summary of the Indications for Use and Technological Characteristics.
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE | REFERENCE DEVICES | | EQUIVALENCE
DISCUSSION | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number/
name | K241391
Straumann® PURE
Ceramic Implants | K171769
Straumann® PURE
Ceramic Implants | K180477
Straumann PURE
Ceramic Implant System | K210336
Neodent Implant
System - Zirconia
Implant System | K201491
Neodent Implant
System - Zirconia
Implant System | |
| Indications
for Use | The Straumann® PURE
Ceramic Implant is
indicated for restoration in
single tooth gaps and in
an edentulous or partially
edentulous jaw.
The prosthetic
restorations used are
single crowns, fixed
partial or full dentures,
which are connected to
the implants through the
corresponding
components.
The ø3.3 mm reduced
diameter implants are
recommended for central
and lateral incisors only | The Straumann® PURE
Ceramic Implant
(Monotype) is indicated for
restoration in single tooth
gaps and in an edentulous
or partially edentulous jaw.
The prosthetic restorations
used are single crowns,
fixed partial or full
dentures, which are
connected to the implants
through the corresponding
components.
The ø3.3 mm reduced
diameter implants are
recommended for central
and lateral incisors only | The Straumann PURE
Ceramic Implant is
indicated for the
restoration of single-tooth
gaps and in edentulous or
partially edentulous jaws.
The prosthetic
restorations used are
single crowns, fixed
partial or full dentures,
which are connected to
the implants through the
corresponding
components. | | | Similar to the primary
predicate, the word
monotype was
removed since the
subject devices
encompass
monotype and two-
piece devices. |
| Material | Yttrium-stabilized
zirconium dioxide (Y-TZP) | Yttrium-stabilized
zirconium dioxide (Y-TZP) | Yttrium-stabilized
zirconium dioxide (Y-TZP) | Yttrium-stabilized
zirconium dioxide (Y-TZP) | Yttrium-stabilized
zirconium dioxide (Y-TZP) | Identical to primary
predicate |
| Surface
Treatment | Sand-blasted, large-grit,
acid etched (ZLA®) | Sand-blasted, large-grit,
acid etched (ZLA®) | Sand-blasted, large-grit,
acid etched (ZLA®) | Sand-blasted, acid
etched | Sand-blasted, acid etched | Identical to primary
predicate |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE | REFERENCE DEVICES | | | EQUIVALENCE
DISCUSSION |
| K Number/
name | K241391
Straumann® PURE
Ceramic Implants | K171769
Straumann® PURE
Ceramic Implants | K180477
Straumann PURE
Ceramic Implant System | K210336
Neodent Implant
System - Zirconia
Implant System | K201491
Neodent Implant
System - Zirconia
Implant System | |
| Implant
Diameter | Ø3.3 and Ø4.1 mm | Ø3.3 and Ø4.1 mm | Ø4.1 mm | Ø3.75 mm | Ø4.3 mm | Identical to reference
devices K180477 and
K171769. |
| Implant
Length | 8, 10, 12 and 14 mm | 8, 10, 12 and 14 mm | 8, 10, 12 and 14 mm | 10, 11.5 and 13 mm | 8, 10, 11.5 and 13 mm | Identical to reference
devices K180477 and
K171769. |
| Implant
Design | Straight cylindrical implant
body & Cylindrical
Monotype | Cylindrical Monotype | Straight cylindrical implant
body | Apically Tapered format
Trapezoidal threads
profile | Apically Tapered format
Trapezoidal threads
profile | Identical to reference
devices K180477 and
K171769. |
| Thread Pitch | 0.8 mm | 0.8 mm | 0.8 mm | n/a | n/a | Identical to reference
devices K180477 and
K171769. |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide
(K171769)
Plasma (K151328) | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Identical to reference
devices K180477 and
K171769. |
8
Straumann® PURE Ceramic Implants
K241391 510(k) Summary
9
Straumann® PURE Ceramic Implants
K241391 510(k) Summary
Materials
The purpose of this submission is to support a change in the raw material supplier. The Straumann® PURE Ceramic Implants are made of Yttrium-stabilized zirconium dioxide (Y-TZP).
Summary of Nonclinical Testing
Nonclinical testing data submitted or referenced to demonstrate substantial equivalence in this 510(k) includes:
- Dynamic fatigue testing was conducted according to the FDA quidance document . "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants" and demonstrated the subject devices are equivalent to the primary predicate and reference devices. The test was conducted in saline (2 Hz and 37°C) at 2 million cycles.
- . Biological assessment was performed according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and to the FDA Guidance document Use of International Standard ISO 10993- 1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, (September 8, 2023). Cytotoxicity and chemical extraction tests were performed. No leachable substances were released in cytotoxic concentrations from the test item.
- K180477 & K171769 (Institut Straumann AG) referenced for sterilization validation in . accordance with ISO 11135, "Sterilization of health care products -- Ethylene oxide --Requirements for the development, validation and routine control of a sterilization process for medical devices," using the Half Cycle approach of the Overkill method. The subject devices are not represented to be "non-pyrogenic".
- K180477 & K171769 (Institut Straumann AG) referenced for the packaging stability . study and shelf-life study in accordance with ASTM F1980.
- The Straumann PURE Ceramic implants are non-magnetic and do not include an electrical . component. As such, the subject devices are not acted upon by the application of
10
Straumann® PURE Ceramic Implants
K241391 510(k) Summary
magnetic fields typical of Magnetic Resonance Imaging equipment. Therefore, the Straumann PURE Ceramic Implants do not raise concerns regarding electromagnetic compatibility and electrical safety, as the reference devices K180477 and K171769. However, the prosthetic components could be manufactured from metal material that can be affected by MRI environment. The MRI compatibility status must consider the clinically relevant construction, which may include assembly with metal devices that can be affected by MRI such as abutments and screws. Therefore, all devices are deemed to be MR Conditional.
- The ZLA® surface features a topography characterized by macro- and micro-roughness . of the subject devices and is identical to the reference devices cleared under K180477 and K171769.
Conclusion
The data included in this submission demonstrate substantial equivalence to the predicate device listed above. Performance testing and comparison to previous clearances show that the subject devices are substantially equivalent.