(302 days)
No.
The device description and intended use focus on the material, design, and function of dental implants, without any mention of computational models, data processing, or AI technologies.
Yes
The device is described as a dental implant system designed to restore patient aesthetics and chewing function by retaining fixed prosthetic devices, which aligns with the definition of a therapeutic device.
No
The device is a dental implant system used for restoring patient aesthetics and chewing function, not for diagnosing medical conditions.
No
The device is a physical medical device (dental implants and abutments made of ceramic material) used for surgical implantation, not a software-only medical device. The description clearly outlines its material, dimensions, and physical application.
No.
The device is a dental implant, which is surgically implanted in the maxilla and mandible to support prosthetic devices. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies. The CeraRoot TL implants are the two-piece tissue level variant of the original CeraRoot implant system (one-piece). CeraRoot TL abutments are industrially manufactured prosthetic components made out from the same material as the implant.
Product codes
DZE, NHA
Device Description
4.1. CeraRoot TL dental implant
The CeraRoot TL Implant System is the two-piece tissue level variant of the original ceramic dental implant one-piece CeraRoot Implant System (K093595) available since 2011 in the USA and 2006 in Europe. CeraRoot® dental implants are made of Y-TZP zirconium dioxide ceramics in accordance with ISO 13356. CeraRoot® dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The outer surface is acid etched for good osseointegration. The new TL (two-piece) variants are available in different lengths (8,10, 12 and 14mm) and only for the models CeraRoot 34TL (⌀ 5mm), CeraRoot 21TL (⌀ 5.6mm) and CeraRoot 16TL (⌀ 7mm).
The implants are provided sterile in sterile packaging and are intended for single use. CeraRoot implants must not be re-sterilized or disinfected either.
4.2. CeraRoot TL abutments
The CeraRoot TL abutments are made of the same Y-TZP ceramic material as the implants, and are attached to the CeraRoot TL implants by cementation. After the cementation of the abutments into the implant then the restorative prosthesis can be custom-made, produced and cemented on top to finish the treatment.
The CeraRoot TL abutments are available with the lengths 4.3 and 5.8 mm.
The CeraRoot TL abutments are provided non-sterile. They are intended for single use and must not be reused. Before use they must be cleaned, disinfected and sterilized according to the instructions given in the "instructions for use of CeraRoot TL abutments" document.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla and mandible
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
8.2. Performance testing
Performance testing of CeraRoot TL implant system was planned regarding the risk analysis according to ISO 14971.
The indicated performance tests were derived and have been projected. As a result of the risk analysis and regarding the applicable FDA guidance the laboratory testing "fatigue testing according to ISO14801" was identified as essential. The testing results were analyzed and evaluated. They demonstrate that the CeraRoot TL implant system meets the existing requirements and acceptance criteria like the predicate devices.
Other tests like biocompatibility, sterility, packaging integrity were discarded based on the risk analysis because it was already covered by the primary predicate device which was identical in raw material and the whole manufacturing process. No additional risks were identified for the new subject device CeraRoot TL two-piece variant. The validation results of the original primary predicate have demonstrated that the cleaning, disinfection and sterilization process meet the defined results.
For the acid etched surface finish, the primary predicate, K093595, included testing for SEM surface analysis and surface topography."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K190406, K132881, K163043, K180477, K091019, K153493
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
FDA 510(k) Clearance Letter - CeraRoot TL Implant System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
CeraRoot SL
Josep Oliva-Ochoa
Dentist- Implantologist / President
Parpers 13
Les Franqueses del Valles, Barcelona 08520
SPAIN
Re: K242072
Trade/Device Name: CeraRoot TL Implant System (TL)
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Dental Implant
Regulatory Class: Class II
Product Code: DZE, NHA
Dated: March 18, 2025
Received: April 17, 2025
Dear Josep Oliva-Ochoa:
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.
May 14, 2025
Page 2
K242072 - Josep Oliva-Ochoa Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K242072 - Josep Oliva-Ochoa Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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
Page 4
FORM FDA 3881 (6/20) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K242072
Device Name: CeraRoot TL Implant System (TL)
Indications for Use (Describe):
CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
The CeraRoot TL implants are the two-piece tissue level variant of the original CeraRoot implant system (one-piece). CeraRoot TL abutments are industrially manufactured prosthetic components made out from the same material as the implant.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510 (k) Summary
510(k) number: K242072
1. Submitters contact information:
CeraRoot S.L.
Address: Parpers, 13. 08520 Les Franqueses del Vallès .(Barcelona) SPAIN
Phone: (+34)768 3962 (+1)800 485 1613
Contact persons: Josep Oliva-Ochoa, Xavier Oliva-Ochoa
Email: josep.oliva@ceraroot.com xavi.oliva@ceraroot.com
Date written: May 13, 2025.
2. Device name and classification
Trade Name: CeraRoot TL Implant System
Common Name: Endosseous Dental Implant
Classification Name: Endosseous Dental Implant
Primary Product Code: DZE
Secondary Product Code: NHA
Regulation Number: 21 CFR 872.3640
Classification: Class II
3. Predicate Devices
3.1. Primary predicate device CeraRoot TL Implant System
| Device | Device Owner/Trade Name | 510(k) # | Product Code |
|---|---|---|---|
| Primary Predicate | CeraRoot SL / CeraRoot Implant System | K093595 | DZE (Implant, Endosseous, Root-Form) |
3.2. Reference devices CeraRoot TL Implant System
| Device | Device Owner/Trade Name | 510(k) # | Product Code |
|---|---|---|---|
| Reference | Swiss Dental Solutions SDS2.2 dental implant | K190406 | DZE (Implant, Endosseous, Root-Form) |
| Reference | Z-Systems AG Z5c Dental Implant | K132881 | DZE (Implant, Endosseous, Root-Form) |
| Reference | Dental Point AG Zeramex® P6 Dental Implant System | K163043 | DZE (Implant, Endosseous, Root-Form) |
| Reference | Straumann USA LLC Straumann PURE CeramicImplant System | K180477 | DZE (Implant, Endosseous, Root-Form) |
Page 6
3.3. Reference devices CeraRoot TL abutments
| Device | Device Owner/Trade Name | 510(k) # | Product Code |
|---|---|---|---|
| Reference | Swiss Dental Solutions SDS2.2 dental implant | K190406 | NHA (Endosseous Dental Implant Abutment) |
| Reference | Z-Systems AG Z5c Dental Implant | K132881 | NHA (Endosseous Dental Implant Abutment) |
| Reference | Dental Point AG Zeramex® P6 Dental Implant System | K163043 | NHA (Endosseous Dental Implant Abutment) |
| Reference | Straumann USA LLC Straumann PURE CeramicImplant System | K180477 | NHA (Endosseous Dental Implant Abutment) |
3.4. Other Reference devices
| Device | Device Owner/Trade Name | 510(k) # | Product Code |
|---|---|---|---|
| Reference | IVOCLAR VIVADENT INC. SPEEDCEM | K091019 | EMA (Cement, Dental) |
| Reference | VOCO GmbH Clip Flow | K153493 | EBF (Material, Tooth Shade, Resin) |
4. Device Description
4.1. CeraRoot TL dental implant
The CeraRoot TL Implant System is the two-piece tissue level variant of the original ceramic dental implant one-piece CeraRoot Implant System (K093595) available since 2011 in the USA and 2006 in Europe. CeraRoot® dental implants are made of Y-TZP zirconium dioxide ceramics in accordance with ISO 13356. CeraRoot® dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The outer surface is acid etched for good osseointegration. The new TL (two-piece) variants are available in different lengths (8,10, 12 and 14mm) and only for the models CeraRoot 34TL (⌀ 5mm), CeraRoot 21TL (⌀ 5.6mm) and CeraRoot 16TL (⌀ 7mm).
The implants are provided sterile in sterile packaging and are intended for single use. CeraRoot implants must not be re-sterilized or disinfected either.
4.2. CeraRoot TL abutments
The CeraRoot TL abutments are made of the same Y-TZP ceramic material as the implants, and are attached to the CeraRoot TL implants by cementation. After the cementation of the abutments into the implant then the restorative prosthesis can be custom-made, produced and cemented on top to finish the treatment.
The CeraRoot TL abutments are available with the lengths 4.3 and 5.8 mm.
The CeraRoot TL abutments are provided non-sterile. They are intended for single use and must not be reused. Before use they must be cleaned, disinfected and sterilized according to the instructions given in the "instructions for use of CeraRoot TL abutments" document.
Page 7
5. Indications for use
| Primary Predicate Device | Proposed Device | |
|---|---|---|
| 510k no. | K093595 | Subject K242072 |
| Trade Name | CeraRoot Implant System | CeraRoot TL Implant System |
| Product Code | DZE (Implant, Endosseous, Root-Form) | DZE (Implant, Endosseous, Root-Form) |
| Secondary Code | / | NHA (Endosseous Dental Implant Abutment) |
| Indications for use | CeraRoot dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed in immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies. | CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies. The CeraRoot TL implants are the two-piece tissue level variant of the original CeraRoot implant system (one-piece). CeraRoot TL abutments are industrially manufactured prosthetic components made out from the same material as the implant. |
The Indications for Use of the subject device are the same as of the primary predicate device with only some minor differences as described hereafter. The prosthetic components (abutments) are different due to the two-piece design of the subject device compared to the one-piece design of the primary predicate device. The use of these components with the subject device are consistent with the use of similar components of the primary predicate device and therefore do not raise new questions about the safety and effectiveness when compared to the predicate device.
5.1. Comparison of the modified proposed/subject device to the primary cleared device in tabular format
| Primary Predicate Device | Proposed Device | |
|---|---|---|
| 510k no. | K093595 | Subject K242072 |
| Trade Name | CeraRoot Implant System | CeraRoot TL Implant System |
| Product Code | DZE (Implant, Endosseous, Root-Form) | DZE (Implant, Endosseous, Root-Form) |
| Secondary Code | / | NHA (Endosseous Dental Implant Abutment) |
| Indications for use | CeraRoot dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed in immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. The CeraRoot dental implants are | CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in |
Page 8
| Primary Predicate Device | Proposed Device | |
|---|---|---|
| 510k no. | K093595 | Subject K242072 |
| Trade Name | CeraRoot Implant System | CeraRoot TL Implant System |
| specially indicated in patients with metal allergies and chronic illness due to metal allergies. | patients with metal allergies and chronic illness due to metal allergies. The CeraRoot TL implants are the two-piece tissue level variant of the original CeraRoot implant system (one-piece). CeraRoot TL abutments are industrially manufactured prosthetic components made out from the same material as the implant. | |
| Material | Y-TZP according to ISO 13356 | Y-TZP according to ISO 13356 |
| Production Process | Milling and Sintering | Milling and Sintering |
| Surface finish | Acid Etching | Acid Etching |
| Sterilization | Ethylene oxide | Ethylene oxide |
| Packaging | Primary: vial and SBS Secondary: Carton Box | Primary: vial and SBS Secondary: Carton Box |
| Restoration | one-piece implant system | Two-piece implant system |
| Abutment | Build-in with the implant | Separate device, to be cemented on the implant after its osseointegration |
Model Specifications
| Model | Primary Predicate Device | Proposed Device |
|---|---|---|
| CeraRoot 12 | L(mm): 8,10,12,14 | |
| ⌀ (mm) intrabone: 4.1 | ||
| ⌀ (mm) prosthetic: 4.1 | ||
| Abutment height: 5 | No TL variant | |
| CeraRoot 14 | L(mm): 10,12,14 | |
| ⌀ (mm) intrabone: 3.5-4.8 | ||
| ⌀ (mm) prosthetic: 5-7 | ||
| Abutment height: 4 | No TL variant | |
| CeraRoot 34 | L(mm): 8,10,12,14 | |
| ⌀ (mm) intrabone: 4.1-4.8 | ||
| ⌀ (mm) prosthetic: 5 | ||
| Abutment height: 4.3 | L(mm): 8,10,12,14 | |
| ⌀ (mm) intrabone: 4.1-4.8 | ||
| ⌀ (mm) prosthetic: 5 | ||
| Abutment height: 4.3, 5.8 | ||
| CeraRoot 34L | L(mm): 8,10,12,14 | |
| ⌀ (mm) intrabone: 4.1-4.8 | ||
| ⌀ (mm) prosthetic: 5 | ||
| Abutment height: 5.8 | No TL variant | |
| CeraRoot 21 | L(mm): 10,12,14 | |
| ⌀ (mm) intrabone: 4.1-4.8 | ||
| ⌀ (mm) prosthetic: 6 | ||
| Abutment height: 6.2 | L(mm): 8,10,12,14 | |
| ⌀ (mm) intrabone: 4.1-4.8 | ||
| ⌀ (mm) prosthetic: 5.6 | ||
| Abutment height: 4.3, 5.8 | ||
| CeraRoot 11 | L(mm): 10,12,14 | |
| ⌀ (mm) intrabone: 4.8-6 | ||
| ⌀ (mm) prosthetic: 6.5 | ||
| Abutment height: 7 | No TL variant | |
| CeraRoot 16 | L(mm): 10,12,14 | |
| ⌀ (mm) intrabone: 4.8-6.5 | ||
| ⌀ (mm) prosthetic: 8 | ||
| Abutment height: 4 | L(mm): 8,10,12,14 | |
| ⌀ (mm) intrabone: 4.8-6.5 | ||
| ⌀ (mm) prosthetic: 7 | ||
| Abutment height: 4.3, 5.8 |
New product references (REF):
| DZE (Implant, Endosseous, Root-Form) | NHA (Endosseous Dental Implant Abutment) | |
|---|---|---|
| Implant Models | REF: | REF: |
| 34TL | 342.008 - (8mm) | 342.104 - (4.3mm) |
Page 9
| DZE (Implant, Endosseous, Root-Form) | NHA (Endosseous Dental Implant Abutment) | |
|---|---|---|
| 342.010 - (10mm) | ||
| 342.012 - (12mm) | ||
| 342.014 (14mm) | 342.106 - (5.8mm) | |
| 21TL | 212.008 - (8mm) | |
| 212.010 - (10mm) | ||
| 212.012 - (12mm) | ||
| 212.014 (14mm) | 342.104 - (4.3mm) | |
| 342.106 - (5.8mm) | ||
| 16TL | 162.008 - (8mm) | |
| 162.010 - (10mm) | ||
| 162.012 - (12mm) | ||
| 162.014 - (14mm) | 162.104 - (4.3mm) | |
| 162.106 - (5.8mm) | ||
| Material | Y-TZP according to ISO 13356 | Y-TZP according to ISO 13356 |
Bellow reference devices were also used in this premarket notification to capture technological characteristics found in the subject device that were not present in the primary predicate device (due to its one-piece design). These minor differences in technical characteristics as identified in the table below do not raise any new questions of safety and effectiveness between the subject and primary predicate device, as these differences are present in the reference devices, which have undergone FDA review and are legally marketed
| DZE (Implant, Endosseous, Root-Form) | NHA (Endosseous Dental Implant Abutment) | |
|---|---|---|
| 342.010 - (10mm) | ||
| 342.012 - (12mm) | ||
| 342.014 (14mm) | 342.106 - (5.8mm) | |
| 21TL | 212.008 - (8mm) | |
| 212.010 - (10mm) | ||
| 212.012 - (12mm) | ||
| 212.014 (14mm) | 342.104 - (4.3mm) | |
| 342.106 - (5.8mm) | ||
| 16TL | 162.008 - (8mm) | |
| 162.010 - (10mm) | ||
| 162.012 - (12mm) | ||
| 162.014 - (14mm) | 162.104 - (4.3mm) | |
| 162.106 - (5.8mm) | ||
| Material | Y-TZP according to ISO 13356 | Y-TZP according to ISO 13356 |
Bellow reference devices were also used in this premarket notification to capture technological characteristics found in the subject device that were not present in the primary predicate device (due to its one-piece design). These minor differences in technical characteristics as identified in the table below do not raise any new questions of safety and effectiveness between the subject and primary predicate device, as these differences are present in the reference devices, which have undergone FDA review and are legally marketed
Page 10
6. Comparison of Technological characteristics of substantial equivalence devices
| FEATURE | PROPOSED Subject K242072 CeraRoot TL Implant System | PRIMARY PREDICATE K093595 CeraRoot Implant System | REFERENCE DEVICES | ||||
|---|---|---|---|---|---|---|---|
| K190406 SDS2.2 dental implant | K132881 Z5c | K163043 Zeramex® P6 | K180477 PURE Ceramic Implant System | ||||
| Indications for use | CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies. The CeraRoot TL implants are the two-piece tissue level variant of the original CeraRoot implant system (one-piece). CeraRoot TL abutments are industrially manufactured prosthetic components made out from the same material as the implant. | CeraRoot dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed in immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies. | SDS2.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations. | Z5c implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5c implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Z5c implants are intended for delayed loading. | The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations. The Zeramex® P6 implants are intended for delayed loading. The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances. The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral incisor in the upper jaw. | 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. The CI RD Straumann PUREbase Abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. | |
| Design | Two-Piece | one-piece | Two-Piece | Two-Piece | Two-Piece | Two-Piece | |
| Implant abutment connection | Cemented | NA | Cemented | Screw-Cement | Screw | Screw Cement | |
| Cement used | SPEEDCEM (K091019) | NA | Ketac Cem (K002793) | Panavia (K032455) | Panavia (K032455) | NA | |
| Restoration Mode of attachment | Cemented | Cemented | Cemented | Cemented | Cemented | Cemented | |
| Material | Y-TZP according to ISO 13356 | Y-TZP according to ISO 13356 | Y-TZP according to ISO 13356 | Aluminum toughened zirconia | Aluminum toughened zirconia | Y-TZP according to ISO 13356 |
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| FEATURE | PROPOSED Subject K242072 CeraRoot TL Implant System | PRIMARY PREDICATE K093595 CeraRoot Implant System | REFERENCE DEVICES | ||||
|---|---|---|---|---|---|---|---|
| K190406 SDS2.2 dental implant | K132881 Z5c | K163043 Zeramex® P6 | K180477 PURE Ceramic Implant System | ||||
| Manufacturing Technology | Turning | Turning | Turning | Turning | Turning | CIM | |
| Implant endosteal Length | 8, 10, 12 and14 mm | 8, 10, 12 and 14 mm | 8, 11 and 14 mm | 10, 11.5, 13 and 14 mm | 8, 10 and 12 mm | 8, 10, 12 and 14 mm | |
| Implant Coronal diameter | Ø5, 5.6 and 7 mm | Ø4.1, 5, 6.5, 7 and 8 mm | Ø5 and 6 mm | Ø4.8 and 6mm | Ø4 and 4.8 mm | Ø3.5 and 4.8 mm | |
| Implant endosteal diameter | Ø4.8 and 6.5 mm | Ø4.1, 4.8, and 6.5 mm | Ø | Ø4 and 5mm | Ø3.3, 4.1 and 4.8 mm | Ø3.3 and 4.1 mm | |
| Abutment material | Y-TZP according to ISO 13356 | NA | Y-TZP according to ISO 13356 | Aluminum toughened zirconia | Aluminum toughened zirconia | Ti-6Al-7Nb | |
| Abutment height | 4.3 and 5.8 mm | NA | 2mm | 4.5 and 5.5 mm | 5.5, 6.5 and 7mm | 6.5 and 8 mm | |
| Abutment angulation | 0º (straight) | NA | 0º (straight) 15º (angled) | 0º (straight) 15º (angled) | 0º (straight) | 0º (straight) | |
| Sterilization method | Ethylene Oxide | Ethylene Oxide | Radiation | Plasma | Steam | Ethylene Oxide | |
| Surface finish | Acid Etched | Acid Etched | Sand Blasted | Grit blasted and laser modified | Sandblasted and etched | Sand blasted acid etched |
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Special 510 (k) Summary
7. Substantial equivalence discussion
7.1. Substantial equivalence discussion CeraRoot TL implant system
As demonstrated in the substantial equivalence discussion the CeraRoot TL implant subject device is equivalent to the selected predicate devices.
The subject device is equivalent to the primary predicate device in terms of intended use, technological characteristics, material and design key elements (including diameter and length, production technology, implant surface topography, sterile packaging, shoulder design, etc.).
Certain differences from the primary predicate device are covered by the reference devices as follows:
-
In terms of anti-rotation protection, the subject device is designed with an internal heart shape, while the primary predicate device features a one-piece design. This difference is covered by the reference devices K190406 and K163043, which are also providing an internal hexagon for anti-rotation protection.
-
Regarding available abutments, the primary predicate device features a one-piece design that requires no additional abutments. This difference is covered by the reference devices K132881, K190406 and K163043, which are containing abutments in similar designs.
-
In regard to protecting the implant connection without a cover screw during the healing phase, the subject device uses temporary filling material and PTFE to seal the connection. This difference was tested with end-users and demonstrated removal of the material intact with no damage to the internal connection.
Based on this comparison it can be concluded that the subject device is substantially equivalent to the predicate devices listed.
7.2. Substantial equivalence discussion CeraRoot TL abutments
As demonstrated in the substantial equivalence discussion the CeraRoot TL subject device is equivalent to the selected predicate devices.
CeraRoot TL abutments are substantially equivalent in terms of material, intended use, indications for use and geometry to the reference devices listed above.
Certain differences from the reference devices are covered by following facts:
-
Regarding the cements used for bonding, CeraRoot TL implant posts are required to be bonded using the dental cement SpeedCem™, Ketac™Cem Automix, whereas the reference devices recommend Ketac™Cem Automix and Panavia™ SA Cement Automix. The difference is bridged by the fact that all stated dental cements are cleared medical devices, cleared under K091019, K032455 and K002793.
-
Additionally, the dental cement SpeedCem™ (K091019) has been tested successfully in the context of fatigue testing according to ISO 14801.
-
The subject device utilizes cementation of the restoration onto the implant gingival collar, which is similar to that in K190406 but does not include reduction of the gingival collar. Instead, the device requires the creation of a feather margin to promote a proper emergence profile and retaining a minimum of 5mm of stump height combining the implant and abutment. This is necessary to ensure prosthesis retention and reduce the risk of debonding.
Based on this comparison it can be concluded that the subject device is substantially equivalent to the predicate devices listed.
8. Non clinical testing
8.1. Biocompatibility
Concerning biocompatibility, the components of the CeraRoot TL implant system described in the biocompatibility document were subjected to a biological evaluation according to ISO 10993-1 including cytotoxicity tests according to ISO 10993-5.
For the manufacturing of CeraRoot TL implant system, identical materials are used in the primary predicate devices with the same type and duration of patient contact (see also substantial equivalence comparison). Concerning the residues from manufacturing processes, the biocompatibility is demonstrated by the tests regarding Cytotoxicity, Bioburden and Endotoxins by an accredited laboratory.
The methods applied for manufacturing, cleaning and sterilization are established validated procedures for several years and are identical to the methods applied for the primary predicate device, cleared under K093595.
Biological evaluation for ethylene oxide sterilization residuals according to ISO 10993-7 was conducted in the primary predicate, K093595."
8.2. Performance testing
Performance testing of CeraRoot TL implant system was planned regarding the risk analysis according to ISO 14971.
The indicated performance tests were derived and have been projected. As a result of the risk analysis and regarding the applicable FDA guidance the laboratory testing "fatigue testing according to ISO14801" was identified as essential. The testing results were analyzed and evaluated. They demonstrate that the CeraRoot TL implant system meets the existing requirements and acceptance criteria like the predicate devices.
Other tests like biocompatibility, sterility, packaging integrity were discarded based on the risk analysis because it was already covered by the primary predicate device which was identical in raw material and the whole manufacturing process. No additional risks were identified for the new subject device CeraRoot TL two-piece variant. The validation results of the original primary predicate have demonstrated that the cleaning, disinfection and sterilization process meet the defined results.
For the acid etched surface finish, the primary predicate, K093595, included testing for SEM surface analysis and surface topography."
9. Sterilization validation and shelf life.
The sterilization and shelf life validations have been performed with the primary predicate CeraRoot implant system (K093595 the original one-piece variant). The one-piece (predicate device) and two-piece implants (subject device) are two implant variants that share the same and exact processes for manufacturing, cleaning, sterilization and packaging. Furthermore, a risk analysis (ISO 14971) did not introduce any new risks that may require the realization of a new revalidation.
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The sterilization validation was conducted in compliance with ISO 11135. The validation results have proved a sterility assurance level of ≤ 10⁻⁶. For the packaging system a performance validation acc. to ISO 11607-1 and ISO 11607-2 was completed. The validation results have demonstrated that the packaging system for CeraRoot implants fulfilled the requirements regarding the packaging performance during sterilization and storage till 5 years accelerated aging.
For the products provided non-sterile, the validation of end-user sterilization has been performed according to ISO 17665. The validation results have demonstrated that the stated cleaning, disinfection and sterilization process meet the defined results.
10. Animal testing
Not applicable, bench testing is performed
11. Clinical testing
Not applicable, CeraRoot TL implant system does not meet one of the characteristics defined by FDA for which clinical studies are needed
12. Summary
Based on the results of Substantial Equivalence Discussion, Performance testing results and the compliance with applicable standards, the CeraRoot TL implant system and abutments are considered substantially equivalent to the named predicate devices.
Existing minor differences in design and technology between the subject device and the predicate devices do not raise any new questions of safety and effectiveness. Therefore, it can be concluded that the CeraRoot TL implant system is substantially equivalent to the predicate devices.
13. Applicable standards
CeraRoot TL implant system meets a number applicable standards including the ones listed in the following table:
| Standard No. | Title | Edition |
|---|---|---|
| Safety / Functional | ||
| EN 1642 | Dentistry. Medical devices for dentistry. Dental Implants | 2011 |
| ISO 13356 | Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) | 2015 |
| EN ISO 14801 | Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants (= ISO 14801:2016) | 2016 |
| ISO 6872 | Dentistry - Ceramic materials. | 2015 / Amd. 1:2018 |
| Biocompatibility | ||
| ISO 10993-1 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process | 2018 |
| ISO 10993-5 | Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | 2009 |
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| Standard No. | Title | Edition |
|---|---|---|
| ISO 10993-7 | Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals. | 2008 |
| ISO 10993-12 | Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | 2021 |
| Sterilization | ||
| EN ISO 11135 | Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices (= ISO 11135:2014) | 2014 |
| ISO 11135 | Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices (= EN ISO 11135:2014/ A1:2019) | 2014 / Amd. 1:2018 |
| EN 556-1 | Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices. | 2001 |
| EN ISO 11607-1 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (=ISO 11607-1: 2019) | 2020 |
| EN ISO 11607-1 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (=ISO 11607-1: 2019) | 2020 / Amd A11:2022 |
| EN ISO 11607-2 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (= ISO 11607-2:2019) | 2020 |
| EN ISO 11607-2 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly process | 2020 / Amd A11:2022 |
| ISO 14644-1 | Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration. | 2015 |
| ISO 14644-2 | Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. | 2015 |
| ISO 11737-1 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products | 2018 +A1:2021 |
| ISO 11737-2 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | 2019 |
| ISO 11138-1 | Sterilization of health care products — Biological indicators — Part 1: General requirements | 2017 |
| ISO 11138-2 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes | 2017 |
| EN ISO 14937 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009). | 2010 |
| ISO 17665 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices | 2024 |
| ISO 19227 | Implants for surgery - Cleanliness of orthopedic implants - General requirements. | 2018 |
| DIN 58953-6 | Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized | 2023 |
| ASTM F1929-23 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | 2023 |
| DIN EN 868-5 | Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods; German version EN 868-5:2018 | 2019 |
| Horizontal standards |
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| Standard No. | Title | Edition |
|---|---|---|
| EN ISO 13485 | Medical devices -- Quality management systems -- Requirements for regulatory purposes (Annexes ZA, ZB, ZC, ZD and ZE). | 2016 +A11:2021 |
| EN ISO 15223-1 | ISO 15223-1:2021 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements | 2021 |
| EN ISO 20417 | Medical Devices-Information to be supplied by the manufacturer. (=> ISO 20417:2021) | 2021 |
| EN ISO 14971 | Medical devices -- Application of risk management to medical devices | 2019/A11:2021 |
| ISO/TR 24971 | Medical Devices - Guidance on the application of ISO 14971. | 2020 |
| ISO 1942 | Dentistry - Vocabulary | 2020 |
| ISO 21531 | Dentistry - Graphical symbols for dental instruments | 2009 |
| ISO 2859-1 | Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection | 1999 |
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| Standard No. | Title | Edition |
|---|---|---|
| EN ISO 13485 | Medical devices -- Quality management systems -- Requirements for regulatory purposes (Annexes ZA, ZB, ZC, ZD and ZE). | 2016 +A11:2021 |
| EN ISO 15223-1 | ISO 15223-1:2021 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements | 2021 |
| EN ISO 20417 | Medical Devices-Information to be supplied by the manufacturer. (=> ISO 20417:2021) | 2021 |
| EN ISO 14971 | Medical devices -- Application of risk management to medical devices | 2019/A11:2021 |
| ISO/TR 24971 | Medical Devices - Guidance on the application of ISO 14971. | 2020 |
| ISO 1942 | Dentistry - Vocabulary | 2020 |
| ISO 21531 | Dentistry - Graphical symbols for dental instruments | 2009 |
| ISO 2859-1 | Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection | 1999 |