(363 days)
No
The summary describes a CAD/CAM system for fabricating temporary dental abutments. It mentions digital scanning and design software but does not include any terms or descriptions indicative of AI or ML technology being used in the design or fabrication process. The performance studies focus on physical properties and fatigue testing, not algorithmic performance.
Yes.
The device is a system for fabricating temporary dental restorations, which are used to treat and restore dental function for up to 12 months.
No
The device is intended for the fabrication of single hybrid abutment crowns for temporary restoration, not for diagnosing a condition or disease.
No
The device is a system that includes physical components (cross-linked polymer block (PMMA), Ti base) and relies on CAD/CAM software for fabrication, but the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Telio CAD Abutment Solutions is a system for creating temporary dental restorations (hybrid abutment crowns) that are cemented to dental implants. It involves scanning the oral cavity or a model and using CAD/CAM technology to fabricate a physical dental device.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient's body. Its function is to design and fabricate a physical dental prosthesis.
Therefore, the Telio CAD Abutment Solutions falls under the category of a dental device, specifically a temporary restorative material and system for creating dental prosthetics, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months).
The system comprises three parts:
- Telio CAD Abutment Solutions
- Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991)
- CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520)
Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below:
-Implant systems:
The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems:
- AstraTech Osseospeed (Dentsply Sirona K130999, K091239)
- Frialit/Xive (Dentsply Sirona K013867))
- internal connection (BioHorizons K143022, K071638, K093321, K042429)
- Replace (Nobel Biocare K020646)
- Nobel Active (Nobel Biocare K071370)
- Bränemark® (Nobel Biocare K022562)
- Tissue Level (Straumann K061176)
- Tapered Screw-Vent (Zimmer K061410)
- Camlog Screw-Line (Camlog K083496)
- Conelog Screw-Line (Camlog K113779)
- iSy (Camlog K133991)
- Osstem TS (Osstem (USA: Hiossen) K121585)
For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single laterial incisors in the maxilla and lateral and central incisors in the mandible.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
Device Description
The Telio® CAD Abutment Solutions- extra systems which is the subject of this premarket notification is a modification to the Telio Abutment Solutions as previously cleared under K151564. The modifications represented in the subject device consist of the addition of 14 extra implant systems to the 2 previously cleared implant systems. The device Telio CAD (K093708) is currently cleared by the FDA as a Crown and Bridge, Temporary Resin (21 C.F.R§872.3770) because it is a device that offers a rapid route to effective temporary restorations. The currently cleared Telio CAD Abutment Solutions (K151564) included the system Straumann Bone Level, but not all the parts of this system (i.e. NC) were mentioned. This submission includes 14 additional systems.
Telio CAD Abutment Solutions- extra systems is intended for use in single hybrid abutment crowns for temporary restoration (up to 12 months). Telio CAD Abutment Solutions is a system comprising of three parts: Telio CAD Abutment Solution, cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base, utilizing Sirona CAD/CAM System to design and fabricate long term temporaries by means of the CAD/CAM technique. The abutments being two-piece titanium base abutments are mated with a PMMA top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment.
For the fabrication of Telio CAD Abutment Solutions, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan, depending on the CAD/CAM system used. For notes regarding the scan, please observe the manufacturer's instructions for use of the CAD/CAM system.
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
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing:
Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: Flexural Strength, Water sorption, Solubility, Flexural modulus, and Ball indentation hardness according to EN 1641:2009. The subject device was tested in direct comparison to the predicate device and the results of the bench testing show the products to be substantially equivalent.
All other applicable non-clinical testing, including sterilization, is leveraged from the listed predicate/reference devices.
Testing Summary:
The device was designed and tested in accordance with guidance document for Root Form Endosseous Dental Implants and Abutments, May 12, 2004 and with ISO 14801:2007 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. This standard is recognized by the FDA under Recognition Number 4-195. All other applicable non-clinical testing is leveraged from the listed predicate/reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION".
November 16, 2020
Ivoclar Vivadent, AG % Lori Aleshin Director of Quality & Regulatory Affairs Ivoclar Vivadent. Inc. 175 Pineview Drive Amherst, New York 14228
Re: K193193
Trade/Device Name: Telio® CAD Abutment Solutions- extra systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: October 1, 2020 Received: October 13, 2020
Dear Lori Aleshin:
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. 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 located 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
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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Telio® CAD Abutment Solutions- extra systems
Indications for Use (Describe)
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months).
The system comprises three parts:
- Telio CAD Abutment Solutions
- Ti base and (Dentsplv Sirona K181520. Camlog K083496. Conelog K143337. iSv K133991)
- CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520)
Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below:
-Implant svstems:
The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems:
- AstraTech Osseospeed (Dentsply Sirona K130999. K091239)
- Frialit/Xive (Dentsplv Sirona K013867))
- internal connection (BioHorizons K143022, K071638, K093321, K042429)
- Replace (Nobel Biocare K020646)
- Nobel Active (Nobel Biocare K071370)
- Bränemark® (Nobel Biocare K022562)
- Tissue Level (Straumann K061176)
- Tapered Screw-Vent (Zimmer K061410)
- Camlog Screw-Line (Camlog K083496)
- Conelog Screw-Line (Camlog K113779)
- iSy (Camlog K133991)
- Osstem TS (Osstem (USA: Hiossen) K121585)
3
| Implant
manufacturer | Implant System | Implant Size
Diameter (mm) | Implant Size
Platform (mm) | TiBase | Dentsply
Sirona Ref. | Interface
size |
|--------------------------|---------------------------------|-------------------------------------|-------------------------------------|--------------------------------------------------------------|-------------------------|-------------------|
| | AstraTech Osseospeed EV 3.6 | 3.6 | 3.6 | AT EV 3.6 GH1 S | 6586312 | S |
| | AstraTech Osseospeed EV 4.2 | 4.2 | 4.2 | AT EV 4.2 GH1 L | 6586320 | |
| | AstraTech Osseospeed EV 4.8 | 4.8 | 4.8 | AT EV 4.8 GH1 L | 6586338 | L |
| | AstraTech Osseospeed EV 5.4 | 5.4 | 5.4 | AT EV 5.4 GH1 L | 6586346 | |
| | AstraTech Osseospeed TX 3.5/4.0 | 3.5 S/ 4.0 S | 3.5/4.0 | AT OS 3.5/4.0 L | 6282532 | |
| | AstraTech Osseospeed TX 4.5/5.0 | 4.5/5.0/5.0 S | 4.5/5.0 | AT OS 4.5/5.0 L | 6282540 | L |
| Dentsply Sirona | Frialit/ Xive 3.4 | 3.4 | 3.4 | FX 3.4 S | 6282433 | S |
| | Frialit/ Xive 3.8 | 3.8 | 3.8 | FX 3.8 S | 6282441 | |
| | Frialit/ Xive 4.5 | 4.5 | 4.5 | FX 4.5 L | 6282458 | |
| | Frialit/ Xive 5.5 | 5.5 | 5.5 | FX 5.5 L | 6282466 | L |
| | internal connection 3.0 | 3.0/3.8 | 3.0 | BH 3.0 S | 6532779 | S |
| BioHorizons | internal connection 3.5 | 3.0/3.5/3.8/4.0/4.6 | 3.5 | BH 3.5 L | 6532894 | |
| | internal connection 4.5 | 4.0/4.6/5.0/5.8 | 4.5 | BH 4.5 L | 6532951 | L |
| | internal connection 5.7 | 5.0/5.8/6.0 | 5.7 | BH 5.7 L | 6536242 | |
| | Replace NP | 3.5 | NP | NB RS 3.5 L | 6282474 | |
| Nobel
Biocare | Replace RP | 4.3 | RP | NB RS 4.3 L | 6282482 | |
| | Replace WP | 5 | WP | NB RS 5.0 L | 6282490 | |
| | Replace 6.0 | 6 | 6.0 | NB RS 6.0 L | 6282508 | |
| | Nobel Active NP | 3.5 | NP | NB A 4.5 L | 6308188 | L |
| | Nobel Active RP | 4.3/5.0 | RP | NB A 5.0 L | 6308253 | |
| | Brånemark NP | 3.3 | NP | NB B 3.4 L | 6282516 | |
| | Brånemark RP | 3.75/4.0 | RP | NB B 4.1 L | 6282524 | |
| | Osstem TS Mini | 3.5 | Mini | O TS 3.5 L | 6527035 | |
| Osstem
(USA: Hiossen) | Osstem TS Standard | 4.0/4.5/5.0/6.0/7.0 | Standard | O TS 4.0 L | 6527043 | L |
| | Bone Level NC | 3.3 | NC (3.3 mm) | S BL 3.3 L | 6308154 | |
| Straumann | Tissue Level RN | 4.8 | RN (4.8) | S SO 4.8 L | 6284249 | L |
| | Tissue Level WN | 6.5 | WM (6.5) | S SO 6.5 L | 6284256 | |
| | Tapered Screw-Vent 3.5 | 3.7/4.1 | 3.5 | Z TSV 3.5 L | 6282581 | |
| Zimmer | Tapered Screw-Vent 4.5 | 4.7 | 4.5 | Z TSV 4.5 L | 6282599 | L |
| | Tapered Screw-Vent 5.7 | 6 | 5.7 | Z TSV 5.7 L | 6282607 | |
| Implant
manufacturer | Implant System | Implant
Size
Diameter
(mm) | Implant
Size
Platform
(mm) | TiBase | Camlog
Ref. | Interface
size |
| Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG Titanium base
CAD/CAM, for Ø 3.3 mm | K2244.3348 | |
| | Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG Titanium base
CAD/CAM, for Ø 3.8 mm | K2244.3848 | S |
| | Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG Titanium base
CAD/CAM, for Ø 4.3 mm | K2244.4348 | |
| | Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG Titanium base
CAD/CAM, for Ø 5.0 mm | K2244.5048 | L |
| | Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG Titanium base
CAD/CAM, for Ø 6.0 mm | K2244.6048 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base
CAD/CAM, for Ø 3.3 mm, GH
0.8 mm | C2242.3308 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base
CAD/CAM, for Ø 3.3 mm, GH
2.0 mm | C2242.3320 | |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base
CAD/CAM, for Ø 3.8 mm, GH
0.8 mm | C2242.3808 | S |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base
CAD/CAM, for Ø 3.8 mm, GH
2.0 mm | C2242.3820 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base
CAD/CAM, for Ø 4.3 mm, GH
0.8 mm | C2242.4308 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base
CAD/CAM, for Ø 4.3 mm, GH
2.0 mm | C2242.4320 | |
| | Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base
CAD/CAM, for Ø 5.0 mm, GH
0.8 mm | C2242.5008 | |
| | Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base
CAD/CAM, for Ø 5.0 mm, GH
2.0 mm | C2242.5020 | L |
| | iSy 3.8 / 4.4 / 5.0 | 3.8/
4.0/
5.0 | 3.8/
4.4/
5.0 | iSy Titanium base CAD/CAM, Ø
4.5 mm, GH 0.8 mm | P2244.4408 | S |
| | iSy 3.8 / 4.4 / 5.0 | 3.8/
4.0/
5.0 | 3.8/
4.4/
5.0 | iSy Titanium base CAD/CAM, Ø
4.5 mm, GH 2.0 mm | P2244.4420 | |
| | iSy 3.8 / 4.4 / 5.0 | 3.8/
4.0/
5.0 | 3.8/
4.4/
5.0 | iSy Titanium base CAD/CAM, Ø
5.2 mm, GH 0.8 mm | P2244.5008 | L |
| | iSy 3.8 / 4.4 / 5.0 | 3.8/
4.0/
5.0 | 3.8/
4.4/
5.0 | iSy Titanium base CAD/CAM, Ø
5.2 mm, GH 2.0 mm | P2244.5020 | |
Dentsply Sirona TiBase
For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single laterial incisors in the maxilla and lateral and central incisors in the mandible.
4
Camlog TiBase
5
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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Image /page/6/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and has the words "Ivoclar" and "Vivadent" stacked on top of each other. Above the words is a curved line of green and blue dots and squares. Below the words is the phrase "passion vision innovation" in red.
Telio® CAD Abutment Solutions- extra systems- K193193
| Contact: | Lori Aleshin, Director of Quality and Regulatory Affairs
Ivoclar Vivadent, Inc.
175 Pineview Drive
Amherst, New York 14228
716-264-2045
lori.aleshin@ivoclarvivadent.com | | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Company: | Ivoclar Vivadent, AG
Bendererstrasse 2, Schaan, FL-9494, Liechtenstein
+423-235-3535 | | |
| Date Prepared: | November 16, 2020 | | |
| Proprietary Name: | Telio® CAD Abutment Solutions- extra systems | | |
| Primary Classification Name: | Endosseous dental implant abutment
(21 CFR 872.3630) | | |
| Primary Product Code: | NHA | | |
| Secondary Product Code: | PNP | | |
| Primary Predicate Device: | Telio® CAD Abutment Solutions (K151564) by Ivoclar Vivadent, AG | | |
| Reference Devices: | Sirona Dental CAD/CAM System (K100152) | | |
| | Sirona Dental CAD/CAM System (K111421) | | |
| | Sirona Dental CAD/CAM System (K181520) | | |
Device Description: The Telio® CAD Abutment Solutions- extra systems which is the subject of this premarket notification is a modification to the Telio Abutment Solutions as previously cleared under K151564. The modifications represented in the subject device consist of the addition of 14 extra implant systems to the 2 previously cleared implant systems. The device Telio CAD (K093708) is currently cleared by the FDA as a Crown and Bridge, Temporary Resin (21 C.F.R§872.3770) because it is a device that offers a rapid route to effective temporary restorations. The currently cleared Telio CAD Abutment Solutions (K151564) included the system Straumann Bone Level, but not all the parts of this system (i.e. NC) were mentioned. This submission includes 14 additional systems.
Telio CAD Abutment Solutions- extra systems is intended for use in single hybrid abutment crowns for temporary restoration (up to 12 months). Telio CAD Abutment Solutions is a system comprising of three parts: Telio CAD Abutment Solution, cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base, utilizing Sirona CAD/CAM System to design and fabricate long term temporaries by means of the CAD/CAM technique. The abutments being two-piece
7
Image /page/7/Picture/1 description: The image is a logo for Ivoclar Vivadent. The logo features the company name in blue, with the word "Ivoclar" on top of the word "Vivadent". Above the company name is a series of green and blue dots and squares. Below the company name is the phrase "passion vision innovation" in red.
titanium base abutments are mated with a PMMA top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment.
For the fabrication of Telio CAD Abutment Solutions, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan, depending on the CAD/CAM system used. For notes regarding the scan, please observe the manufacturer's instructions for use of the CAD/CAM system.
Compatible Systems:
Dentsply Sirona CEREC® and inLab® Updated material and TiBase library datasets relating to Dentsply Sirona's Sirona Dental CAD/CAM System with CEREC SW chairside software are obtained by download at: https://my.cerec.com
For detailed information regarding the use of Dentsply Sirona's Sirona Dental CAD/CAM System with CEREC SW chairside software, please refer to the CAD/CAM system's manual provided by Dentsply Sirona.
| Existing Implant Systems
| (K151564) |
|---|
| Bone Level RC |
| Certain |
| Extra Implant Systems |
|---|
| AstraTech Osseospeed EV 3.6 |
| AstraTech Osseospeed EV 4.2 |
| AstraTech Osseospeed EV 4.8 |
| AstraTech Osseospeed EV 5.4 |
| AstraTech Osseospeed TX 3.5/4.0 |
| AstraTech Osseospeed TX 4.5/5.0 |
| Frialit/ Xive 3.4 |
| Frialit/ Xive 3.8 |
| Frialit/ Xive 4.5 |
| Frialit/ Xive 5.5 |
| internal connection 3.0 |
| internal connection 3.5 |
| internal connection 4.5 |
| internal connection 5.7 |
| Replace NP |
| Replace RP |
| Replace WP |
| Replace 6.0 |
| Nobel Active NP |
| Nobel Active RP |
| Brånemark® NP |
| Brånemark® RP |
| Osstem TS Mini |
| Osstem TS Standard |
| Bone Level NC |
| Tissue Level RN |
| Tissue Level WN |
| Tapered Screw-Vent 3.5 |
| Tapered Screw-Vent 4.5 |
| Tapered Screw-Vent 5.7 |
8
Image /page/8/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the word "Ivoclar" stacked on top of "Vivadent". Above the company name is an arc of green and blue dots and squares. Below the company name is the company slogan, "passion vision innovation".
| Camlog Screw-Line | |
|---|---|
| Conelog Screw-Line | |
| iSy |
Predicate Device: The primary predicate devices to which Telio® CAD Abutment Solutionsextra systems has been compared is Ivoclar Vivadent, AG Telio® CAD Abutment Solutions (K151564).
For this application, Telio® CAD Abutment Solutions- extra systems has been compared to its predicate and found equivalent with regard to the contraindications, biocompatibility, storage, technology and device specification, classification, and storage. The comparison shows that
Telio® CAD Abutment Solutions- extra systems is substantially equivalent to the predicate device.
The indications and working principle only differ in the fact, that Telio CAD Abutment Solutions can now be used with 14 extra systems in addition to the predicate devices 2 implant systems (i.e., Bone Level RC and Certain).
The fatigue testing performed for the listed extra systems proves that Telio CAD Abutment Solutions can be used with the 14 additional implant systems.
9
Image /page/9/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "ivoclar" in green and "vivadent" in blue. Above the company name is a curved line of green and blue squares, and below the name is the company's slogan, "passion vision innovation."
| Technological
Characteristics | Proposed Device:
Telio CAD Abutment
Solutions- extra systems
(K193193) | Primary Predicate Device:
Telio® CAD Abutment
Solutions (K151564) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|--|
| Manufacturer | Ivoclar Vivadent, AG | Ivoclar Vivadent, AG | Dentsply Sirona | Dentsply Sirona | Dentsply Sirona | |
| Indications for
Use:
Telio CAD
Abutment
Solutions- extra
systems
(K193193) | Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12
months).
The system comprises three parts:
- Telio CAD Abutment Solutions
- Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991)
- CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520)
Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants.
The compatible implant systems, CAD/CAM systems and Ti bases are shown below:
-Implant systems:
The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems: - AstraTech Osseospeed (Dentsply Sirona K130999, K091239)
- Frialit/Xive (Dentsply Sirona K013867))
- internal connection (BioHorizons K143022, K071638, K093321, K042429)
- Replace (Nobel Biocare K020646)
– Nobel Active (Nobel Biocare K071370) - Bränemark® (Nobel Biocare K022562) | | | | | |
| Technological
Characteristics | Proposed Device:
Telio CAD Abutment
Solutions- extra systems
(K193193) | Primary Predicate Device:
Telio® CAD Abutment
Solutions (K151564) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) | |
| - Tapered Screw-Vent (Zimmer K061410) - Camlog Screw-Line (Camlog K083496)
- Conelog Screw-Line (Camlog K113779)
- iSy (Camlog K133991)
- Osstem TS (Osstem (USA: Hiossen) K121585) | | | | | | |
10
Image /page/10/Picture/1 description: The image contains the logo for Ivoclar Vivadent. The logo is in blue and green. The words "Ivoclar" and "Vivadent" are stacked on top of each other in a sans-serif font. Above the words is a semi-circle of green and blue dots. Below the words is the phrase "passion vision innovation" in a smaller font.
assion vision innovation
11
Image /page/11/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in blue, with the words "ivoclar" stacked on top of "vivadent." Above the company name is an arc of green and blue dots. Below the company name is the company slogan "passion vision innovation" in a smaller font.
| Implant
manufacturer | Implant System | Implant Size
Diameter (mm) | Implant Size
Platform (mm) | TiBase | Dentsply
Sirona Ref. | Interface
size |
|--------------------------|---------------------------------|-------------------------------|-------------------------------|-----------------|-------------------------|-------------------|
| Dentsply Sirona | AstraTech Osseospeed EV 3.6 | 3.6 | 3.6 | AT EV 3.6 GH1 S | 6586312 | S |
| | AstraTech Osseospeed EV 4.2 | 4.2 | 4.2 | AT EV 4.2 GH1 L | 6586320 | |
| | AstraTech Osseospeed EV 4.8 | 4.8 | 4.8 | AT EV 4.8 GH1 L | 6586338 | L |
| | AstraTech Osseospeed EV 5.4 | 5.4 | 5.4 | AT EV 5.4 GH1 L | 6586346 | |
| | AstraTech Osseospeed TX 3.5/4.0 | 3.5 S/4.05 | 3.5/4.0 | AT OS 3.5/4.0 L | 6282532 | |
| | AstraTech Osseospeed TX 4.5/5.0 | 4.5/5.0/5.0 5 | 4.5/5.0 | AT OS 4.5/5.0 L | 6282540 | L |
| | Frialit/Xive 3.4 | 3.4 | 3.4 | FX 3.4 S | 6282433 | |
| | Frialit/Xive 3.8 | 3.8 | 3.8 | FX 3.8 S | 6282441 | S |
| | Frialit/Xive 4.5 | 4.5 | 4.5 | FX 4.5 L | 6282458 | |
| | Frialit/Xive 5.5 | 5.5 | 5.5 | FX 5.5 L | 6282466 | L |
| BioHorizons | internal connection 3.0 | 3.0/3.8 | 3.0 | BH 3.0 S | 6532779 | S |
| | internal connection 3.5 | 3.0/3.5/3.8/4.0/4.6 | 3.5 | BH 3.5 L | 6532894 | |
| | internal connection 4.5 | 4.0/4.6/5.0/5.8 | 4.5 | BH 4.5 L | 6532951 | L |
| | internal connection 5.7 | 5.0/5.8/6.0 | 5.7 | BH 5.7 L | 6536242 | |
| Nobel
Biocare | Replace NP | 3.5 | NP | NB RS 3.5 L | 6282474 | |
| | Replace RP | 4.3 | RP | NB RS 4.3 L | 6282482 | |
| | Replace WP | 5 | WP | NB RS 5.0 L | 6282490 | |
| | Replace 6.0 | 6 | 6.0 | NB RS 6.0 L | 6282508 | L |
| | Nobel Active NP | 3.5 | NP | NB A 4.5 L | 6308188 | |
| | Nobel Active RP | 4.3/5.0 | RP | NB A 5.0 L | 6308253 | |
| | Brånemark NP | 3.3 | NP | NB B 3.4 L | 6282516 | |
| | Brånemark RP | 3.75/4.0 | RP | NB B 4.1 L | 6282524 | |
| Osstem
(USA: Hiossen) | Osstem TS Mini | 3.5 | Mini | O TS 3.5 L | 6527035 | |
| | Osstem TS Standard | 4.0/4.5/5.0/6.0/7.0 | Standard | O TS 4.0 L | 6527043 | L |
| Straumann | Bone Level NC | 3.3 | NC (3.3 mm) | S BL 3.3 L | 6308154 | |
| | Tissue Level RN | 4.8 | RN (4.8) | S SO 4.8 L | 6284249 | L |
| | Tissue Level WN | 6.5 | WM (6.5) | S SO 6.5 L | 6284256 | |
| Zimmer | Tapered Screw-Vent 3.5 | 3.7/4.1 | 3.5 | Z TSV 3.5 L | 6282581 | |
| | Tapered Screw-Vent 4.5 | 4.7 | 4.5 | Z TSV 4.5 L | 6282599 | L |
| | Tapered Screw-Vent 5.7 | 6 | 5.7 | Z TSV 5.7 L | 6282607 | |
510K Summary Page 6 of 19
12
Image /page/12/Picture/1 description: The image is a logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "ivoclar" in green and "vivadent" in blue. Above the company name is a series of green and blue dots arranged in an arc. Below the company name is the company's slogan, "passion vision innovation."
passion vision innovation
| Technological
Characteristics | Proposed Device:
Telio CAD Abutment
Solutions- extra systems
(K193193) | Primary Predicate Device:
Telio® CAD Abutment
Solutions (K151564) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| | For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of
single laterial incisors in the maxilla and lateral and central incisors in the mandible. | | | | |
13
Image /page/13/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the company name in a blue sans-serif font, with the first word "Ivoclar" stacked on top of the second word "Vivadent". Above the company name is a semi-circle of green and blue dots and squares. Below the company name is the company slogan "passion vision innovation" in a red sans-serif font.
| Implant
Size
Diameter
(mm) | Implant
Size
Platform
(mm) | TiBase | Camlog
Ref. | Interface
size |
|-------------------------------------|-------------------------------------|-----------------------------------------------------|----------------|-------------------|
| 3.3 | 3.3 | CAMLOG* Titanium base
CAD/CAM, for Ø 3.3 mm | K2244.3348 | |
| 3.8 | 3.8 | CAMLOG* Titanium base
CAD/CAM, for Ø 3.8 mm | K2244.3848 | S |
| 4.3 | 4.3 | CAMLOG* Titanium base
CAD/CAM, for Ø 4.3 mm | K2244.4348 | |
| 5.0 | 5.0 | CAMLOG* Titanium base
CAD/CAM, for Ø 5.0 mm | K2244.5048 | L |
| 6.0 | 6.0 | CAMLOG* Titanium base
CAD/CAM, for Ø 6.0 mm | K2244.6048 | |
| | | CONELOG® Titanium base
CAD/CAM, for Ø 3.3 mm, GH | C2242.3308 | |
| Camlog TiBase | ||
|---|---|---|
manufacturer
Implant System
Implant
| Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG Titanium base
CAD/CAM, for Ø 3.3 mm | K2244.3348 | |
|--------|------------------------|---------------------|---------------------|--------------------------------------------------------------|------------|---|
| | Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG Titanium base
CAD/CAM, for Ø 3.8 mm | K2244.3848 | S |
| | Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG Titanium base
CAD/CAM, for Ø 4.3 mm | K2244.4348 | |
| | Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG Titanium base
CAD/CAM, for Ø 5.0 mm | K2244.5048 | L |
| | Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG Titanium base
CAD/CAM, for Ø 6.0 mm | K2244.6048 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base
CAD/CAM, for Ø 3.3 mm, GH
0.8 mm | C2242.3308 | |
| | | 3.3 | 3.3 | CONELOG Titanium base
CAD/CAM, for Ø 3.3 mm, GH
2.0 mm | C2242.3320 | |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base
CAD/CAM, for Ø 3.8 mm, GH
0.8 mm | C2242.3808 | S |
| | | 3.8 | 3.8 | CONELOG Titanium base
CAD/CAM, for Ø 3.8 mm, GH
2.0 mm | C2242.3820 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base
CAD/CAM, for Ø 4.3 mm, GH
0.8 mm | C2242.4308 | |
| | | 4.3 | 4.3 | CONELOG Titanium base
CAD/CAM, for Ø 4.3 mm, GH
2.0 mm | C2242.4320 | |
| | Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base
CAD/CAM, for Ø 5.0 mm, GH
0.8 mm | C2242.5008 | L |
| | | 5.0 | 5.0 | CONELOG Titanium base
CAD/CAM, for Ø 5.0 mm, GH
2.0 mm | C2242.5020 | |
| | iSy 3.8 / 4.4 / 5.0 | 3.8/
4.0/
5.0 | 3.8/
4.4/
5.0 | iSy Titanium base CAD/CAM, Ø
4.5 mm, GH 0.8 mm | P2244.4408 | S |
| | | | | iSy Titanium base CAD/CAM, Ø
4.5 mm, GH 2.0 mm | P2244.4420 | |
| | | | | iSy Titanium base CAD/CAM, Ø
5.2 mm, GH 0.8 mm | P2244.5008 | L |
| | | | | iSy Titanium base CAD/CAM, Ø
5.2 mm, GH 2.0 mm | P2244.5020 | |
14
Image /page/14/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is composed of the company name in a blue, sans-serif font, with the word "Ivoclar" stacked on top of "Vivadent." Above the company name is a curved line of green and blue dots. Below the company name is the company's slogan, "passion vision innovation."
passion vision innovation
| Technological
Characteristics | Proposed Device: | Primary Predicate Device: | Reference
Device: | Reference
Device: | Reference
Device: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | Telio CAD Abutment
Solutions- extra systems
(K193193) | Telio® CAD Abutment
Solutions (K151564) | Sirona Dental
CAD/CAM
System
(K100152) | Sirona Dental
CAD/CAM
System
(K111421) | Sirona Dental
CAD/CAM
System
(K181520) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Indications for
Use:
Telio CAD
Abutment
Solutions
(K151564) | Telio CAD Abutment Solutions is intended for single
hybrid abutment crowns for temporary restoration (up
to 12 months).
The system comprises three parts:
- Telio CAD Abutment Solutions
- Ti base and
- CAD/CAM software
Telio CAD Abutment Solutions is cemented to the Ti
base and used in conjunction with endosseous dental
implants. The compatible implant systems, CAD/CAM
systems and Ti bases are shown below:
-Implant systems: Straumann Bone Level (K053088),
Biomet 3 Certain (K014235)
-CAD/CAM Systems: Sirona inLab and Cerec SW 4.2
and above (K100152 and K111421) - Titanium bases (K100152 and K111421): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Implant
Mfg. Implant
System Implant
Diameter (mm) Ti Base Sirona Ref. Interface size Straumann Bone Level RC 4.1/4.8 S BL 4.1 6308337 L 3.4 BC 3.4 6308048 S Biomet 3i Certain 4.1 BC 4.1 6308097 L 5.0 BC 5.0 6308121 L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
15
Image /page/15/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "ivoclar" in a darker blue and "vivadent" in a lighter blue. Above the company name is a semi-circular arrangement of green and blue squares, creating a visual arc. Below the company name is the tagline "passion vision innovation" in a smaller font.
| Technological
Characteristics | Proposed Device:
Telio CAD Abutment
Solutions- extra systems
(K193193) | Primary Predicate Device:
Telio® CAD Abutment
Solutions (K151564) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use
Differences: | The indications only differ in the fact, that Telio CAD Abutment Solutions now can be used with 13 additional implant systems and Straumann
Bone Level NC. Fatigue testing for the listed extra systems has been performed and discussed more fully in the Performance Testing- Bench
section of this application.
Therefore the devices are substantially equivalent. | | | | |
| Compatibility | The Telio CAD mesostructure and
TiBase two-piece abutment is
compatible with the following
Implant Systems:
-Dentsply Sirona: Astra Tech
Osseospeed EV
(K130999) Astra Tech
Osseospeed TX (K091239)
Friadent
XiVE (K013867),
-BioHorizons Implant System:
Internal connection
(K143022, K071638, K093321,
K042429)
-Nobel Biocare Replace
(K020646), Active Internal
(K071370) Branemark
(K022562),
-Osstem: TS Implant System
(K121585) | The Telio CAD mesostructured
and TiBase two-piece abutment
is compatible with the following
Implant Systems:
- Biomet 3: Straumann Bone Level
(K053088), - Biomet 3 Certain (K014235) | The InCoris
mesostructured and
TiBase two-piece
abutment is
compatible with the
following implant
systems:
Nobel Biocare:
Replace (K020646)
Nobel Biocare:
Branemark
(K022562)
Friadent Xive
(K013867)
Biomet 3i Osseotite
(K980549) | The InCoris
mesostructured and
TiBase two-piece
abutment is
compatible with the
following implant
systems:
Nobel Biocare
Replace (K020646)
Nobel Biocare
Branemark
(K022562)
Friadent Xive
(K013867)
Biomet 3i Osseotite
(K980549) | The InCoris
mesostructured and
TiBase two-piece
abutment is
compatible with the
following implant
systems:
Nobel Biocare
Replace (K020646)
Nobel Biocare
Active (K071370)
Nobel Biocare
Branemark
(K022562)
Straumann SynOcta
(K061176) |
| Technological
Characteristics | Proposed Device:
Telio CAD Abutment
Solutions- extra systems
(K193193) | Primary Predicate Device:
Telio® CAD Abutment
Solutions (K151564) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) |
| | -Straumann Standard Tissue
Level RN/WN (K061176)
-Zimmer TSV (K061410)
-Camlog: Camlog Screw-Line,
Conelog Screw-Line,
iSy (K083496, K113779,
K133991) | | AstraTech
Osseospeed
(K091239)
Zimmer Tapered
Screw-Vent
(K061410)
Straumann SynOcta
(K061176) | AstraTech
Osseospeed
(K091239)
Zimmer Tapered
Screw-Vent
(K061410)
Straumann SynOcta
(K061176)
Straumann Bone
Level (K053088,
K062129, K060958)
Biomet 3i Certain
(K014235,
K061629)
Nobel Biocare
Active (K071370) | Straumann Bone
Level (K053088,
K062129, K060958)
Dentsply Sirona
Osseospeed
(K091239)
Xive (K013867)
Dentsply Sirona
Osseospeed EV
(K130999)
Dentsply Sirona
Ankylos (K140347,
K083805)
Biomet 3i Osseotite
(K980549)
Biomet 3i Certain
(K014235,
K061629) |
| Technological
Characteristics | Proposed Device:
Telio CAD Abutment
Solutions- extra systems
(K193193) | Primary Predicate Device:
Telio® CAD Abutment
Solutions (K151564) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) |
| | | | | | Zimmer Tapered
Screw-Vent
(K061410)
Thomenn Medical
SPI (K093615,
K090154)
Osstem/Hiossen
Osstem TS/
Hiossen (K121585,
K140934, K101096)
BioHorizons Internal
Connections
(K143022,
K071638, K093321,
K04249) |
| General Design | Telio CAD Abutment
Solutions are polymethyl
methacrylate (PMMA) blocks in
various sizes. One side
of the block is mounted to a
mandrel that will be inserted into
the spindle's clamping chuck of the
grinding machine. The connection | Telio CAD Abutment
Solutions are polymethyl
methacrylate (PMMA) blocks in
various sizes. One side
of the block is mounted to a
mandrel that will be inserted into
the spindle's clamping chuck of the
grinding machine. The connection | | | The Sirona TiBase is a premanufactured prosthetic component
directly connected to endosseous dental implants with a screw and
is intended for use as an aid in prosthetic rehabilitation. |
| Technological
Characteristics | Proposed Device:
Telio CAD Abutment
Solutions- extra systems
(K193193) | Primary Predicate Device:
Telio® CAD Abutment
Solutions (K151564) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) |
| | geometry to titanium bases is
prefabricated, i.e. already included
in the shipped block. Telio CAD
Abutment Solutions is used to
prepare a patient-specific
temporary restoration using
CAD/CAM technology.
The monolithically milled hybrid
abutment crown is extraorally
cemented to the Ti base by means
of Multilink Hybrid Abutment HO 0.
Then the restoration is screwed
onto the implant in one piece.
Finally, the screw channel is sealed
with a composite or a light-curing
temporary restorative material. | geometry to titanium bases is
prefabricated, i.e. already included
in the shipped block. Telio CAD
Abutment Solutions is used to
prepare a patient-specific
temporary restoration using
CAD/CAM technology.
The monolithically milled hybrid
abutment crown is extraorally
cemented to the Ti base by means
of Multilink Hybrid Abutment HO 0.
Then the restoration is screwed
onto the implant in one piece.
Finally, the screw channel is
sealed with a composite or a light-
curing temporary restorative
material. | | | |
| Abutment Angle | 0° | 0° to 20° | 0° to 20° | | |
| Restoration | Temporary Single Unit | Single Unit | Single Unit, Multi-Unit | | |
| Block Material | Polymethyl methacrylate
(PMMA) | Polymethyl methacrylate
(PMMA) | InCoris | InCoris | InCoris |
| Technological
Characteristics | Proposed Device:
Telio CAD Abutment
Solutions- extra systems
(K193193) | Primary Predicate Device:
Telio® CAD Abutment
Solutions (K151564) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K100152) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K111421) | Reference
Device:
Sirona Dental
CAD/CAM
System
(K181520) |
| Cement
(Adhesive) | Multilink Hybrid Abutment | Multilink Hybrid Abutment | Panavia F2.0 | Panavia F2.0 | Panavia F2.0 |
| Sterilization
Method | Autoclave
121°C at 30 min | Autoclave
121°C at 20 min | Steam Sterilization | Steam Sterilization | Steam Sterilization |
| Use | Single Use | Single Use | Single-Use | Single-Use | Single-Use |
16
Image /page/16/Picture/1 description: The image contains the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "ivoclar" stacked above "vivadent". A series of green and blue squares and circles are arranged in an arc above the company name. Below the company name is the phrase "passion vision innovation" in a smaller font.
ssion vision innovation
17
Image /page/17/Picture/1 description: The image contains the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "Ivoclar" in a larger, bolder font above "Vivadent." A series of green and blue dots arc over the company name. The tagline "passion vision innovation" is below the company name in a smaller font.
ssion vision innovation
18
Image /page/18/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "Ivoclar" in a lighter blue and "Vivadent" in a darker blue. Above the company name is a series of green and blue dots arranged in an arc. Below the company name is the tagline "passion vision innovation" in a smaller font.
vation ssion vision inno
19
Image /page/19/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "Ivoclar" in green and "Vivadent" in blue. Above the company name is a curved line of green and blue squares. Below the company name is the company slogan: "passion vision innovation".
passion vision innovation
20
Indications for Use Statement:
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months).
The system comprises three parts:
- Telio CAD Abutment Solutions
- Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991)
- CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520)
Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below:
-Implant systems:
The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems:
- AstraTech Osseospeed (Dentsply Sirona K130999, K091239)
- Frialit/Xive (Dentsply Sirona K013867))
- internal connection (BioHorizons K143022, K071638, K093321, K042429)
- Replace (Nobel Biocare K020646)
- Nobel Active (Nobel Biocare K071370)
- Bränemark® (Nobel Biocare K022562)
- Tissue Level (Straumann K061176)
- Tapered Screw-Vent (Zimmer K061410)
- Camlog Screw-Line (Camlog K083496)
- Conelog Screw-Line (Camlog K113779)
- iSy (Camlog K133991)
- Osstem TS (Osstem (USA: Hiossen) K121585)
21
Dentsply Sirona TiBase
| Implant
manufacturer | Implant System | Implant Size
Diameter (mm) | Implant Size
Platform (mm) | TiBase | Dentsply
Sirona Ref. | Interface
size |
|--------------------------|---------------------------------|-------------------------------|-------------------------------|-----------------|-------------------------|-------------------|
| Dentsply Sirona | AstraTech Osseospeed EV 3.6 | 3.6 | 3.6 | AT EV 3.6 GH1 S | 6586312 | S |
| | AstraTech Osseospeed EV 4.2 | 4.2 | 4.2 | AT EV 4.2 GH1 L | 6586320 | |
| | AstraTech Osseospeed EV 4.8 | 4.8 | 4.8 | AT EV 4.8 GH1 L | 6586338 | L |
| | AstraTech Osseospeed EV 5.4 | 5.4 | 5.4 | AT EV 5.4 GH1 L | 6586346 | |
| | AstraTech Osseospeed TX 3.5/4.0 | 3.5 S/ 4.0 S | 3.5/4.0 | AT OS 3.5/4.0 L | 6282532 | |
| | AstraTech Osseospeed TX 4.5/5.0 | 4.5/5.0/5.0 S | 4.5/5.0 | AT OS 4.5/5.0 L | 6282540 | L |
| | Frialit/Xive 3.4 | 3.4 | 3.4 | FX 3.4 S | 6282433 | S |
| Dentsply Sirona | Frialit/Xive 3.8 | 3.8 | 3.8 | FX 3.8 S | 6282441 | S |
| | Frialit/Xive 4.5 | 4.5 | 4.5 | FX 4.5 L | 6282458 | |
| | Frialit/Xive 5.5 | 5.5 | 5.5 | FX 5.5 L | 6282466 | L |
| BioHorizons | internal connection 3.0 | 3.0/3.8 | 3.0 | BH 3.0 S | 6532779 | S |
| | internal connection 3.5 | 3.0/3.5/3.8/4.0/4.6 | 3.5 | BH 3.5 L | 6532894 | |
| | internal connection 4.5 | 4.0/4.6/5.0/5.8 | 4.5 | BH 4.5 L | 6532951 | L |
| | internal connection 5.7 | 5.0/5.8/6.0 | 5.7 | BH 5.7 L | 6536242 | |
| Nobel
Biocare | Replace NP | 3.5 | NP | NB RS 3.5 L | 6282474 | |
| | Replace RP | 4.3 | RP | NB RS 4.3 L | 6282482 | |
| | Replace WP | 5 | WP | NB RS 5.0 L | 6282490 | |
| | Replace 6.0 | 6 | 6.0 | NB RS 6.0 L | 6282508 | L |
| | Nobel Active NP | 3.5 | NP | NB A 4.5 L | 6308188 | |
| | Nobel Active RP | 4.3/5.0 | RP | NB A 5.0 L | 6308253 | |
| | Brånemark NP | 3.3 | NP | NB B 3.4 L | 6282516 | |
| | Brånemark RP | 3.75/4.0 | RP | NB B 4.1 L | 6282524 | |
| Osstem
(USA: Hiossen) | Osstem TS Mini | 3.5 | Mini | O TS 3.5 L | 6527035 | |
| | Osstem TS Standard | 4.0/4.5/5.0/6.0/7.0 | Standard | O TS 4.0 L | 6527043 | L |
| Straumann | Bone Level NC | 3.3 | NC (3.3 mm) | S BL 3.3 L | 6308154 | |
| | Tissue Level RN | 4.8 | RN (4.8) | S SO 4.8 L | 6284249 | L |
| | Tissue Level WN | 6.5 | WM (6.5) | S SO 6.5 L | 6284256 | |
| Zimmer | Tapered Screw-Vent 3.5 | 3.7/4.1 | 3.5 | Z TSV 3.5 L | 6282581 | |
| | Tapered Screw-Vent 4.5 | 4.7 | 4.5 | Z TSV 4.5 L | 6282599 | |
| | Tapered Screw-Vent 5.7 | 6 | 5.7 | Z TSV 5.7 L | 6282607 | L |
For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single laterial incisors in the maxilla and lateral and central incisors in the mandible.
22
Camlog TiBase
| Implant
manufacturer | Implant System | Implant
Size
Diameter
(mm) | Implant
Size
Platform
(mm) | TiBase | Camlog
Ref. | Interface
size |
|-------------------------|------------------------|-------------------------------------|-------------------------------------|--------------------------------------------------------------|----------------|-------------------|
| Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG Titanium base
CAD/CAM, for Ø 3.3 mm | K2244.3348 | S |
| | Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG Titanium base
CAD/CAM, for Ø 3.8 mm | K2244.3848 | |
| | Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG Titanium base
CAD/CAM, for Ø 4.3 mm | K2244.4348 | |
| | Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG Titanium base
CAD/CAM, for Ø 5.0 mm | K2244.5048 | L |
| | Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG Titanium base
CAD/CAM, for Ø 6.0 mm | K2244.6048 | |
| | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base
CAD/CAM, for Ø 3.3 mm, GH
0.8 mm | C2242.3308 | S |
| | | | | CONELOG Titanium base
CAD/CAM, for Ø 3.3 mm, GH
2.0 mm | C2242.3320 | |
| | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base
CAD/CAM, for Ø 3.8 mm, GH
0.8 mm | C2242.3808 | |
| | | | | CONELOG Titanium base
CAD/CAM, for Ø 3.8 mm, GH
2.0 mm | C2242.3820 | |
| | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base
CAD/CAM, for Ø 4.3 mm, GH
0.8 mm | C2242.4308 | |
| | | | | CONELOG Titanium base
CAD/CAM, for Ø 4.3 mm, GH
2.0 mm | C2242.4320 | |
| | Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base
CAD/CAM, for Ø 5.0 mm, GH
0.8 mm | C2242.5008 | L |
| | | | | CONELOG Titanium base
CAD/CAM, for Ø 5.0 mm, GH
2.0 mm | C2242.5020 | |
| | iSy 3.8 / 4.4 / 5.0 | 3.8/
4.0/
5.0 | 3.8/
4.4/
5.0 | iSy Titanium base CAD/CAM, Ø
4.5 mm, GH 0.8 mm | P2244.4408 | S |
| | | | | iSy Titanium base CAD/CAM, Ø
4.5 mm, GH 2.0 mm | P2244.4420 | |
| | | | | iSy Titanium base CAD/CAM, Ø
5.2 mm, GH 0.8 mm | P2244.5008 | L |
| | | | | iSy Titanium base CAD/CAM, Ø
5.2 mm, GH 2.0 mm | P2244.5020 | |
23
Image /page/23/Picture/1 description: The image is a logo for Ivoclar Vivadent. The logo features the company name in a stylized blue font, with the words "Ivoclar" stacked on top of "Vivadent". Above the company name is a series of green and blue dots and squares arranged in an arc. Below the company name is the slogan "passion vision innovation" in a smaller, black font.
Dentsply Sirona`s TiBases:
All TiBases mentioned in the table manufactured by Dentsply Sirona are cleared under K181520.
Camlog titanium bases:
| Product ID | Product description | 510k
number |
|------------|---------------------------------------------------|----------------|
| K2244.3348 | CAMLOG® Titanium base CAD/CAM Ø 3.3 mm | K083496 |
| K2244.3848 | CAMLOG® Titanium base CAD/CAM Ø 3.8 mm | K083496 |
| K2244.4348 | CAMLOG® Titanium base CAD/CAM Ø 4.3 mm | K083496 |
| K2244.5048 | CAMLOG® Titanium base CAD/CAM Ø 5.0 mm | K083496 |
| K2244.6048 | CAMLOG® Titanium base CAD/CAM Ø 6.0 mm | K083496 |
| C2242.3308 | CONELOG® Titanium base CAD/CAM d 3.3 mm GH 0.8 mm | K143337 |
| C2242.3320 | CONELOG® Titanium base CAD/CAM d 3.3 mm GH 2.0 mm | K143337 |
| C2242.3808 | CONELOG® Titanium base CAD/CAM d 3.8 mm GH 0.8 mm | K143337 |
| C2242.3820 | CONELOG® Titanium base CAD/CAM d 3.8 mm GH 2.0 mm | K143337 |
| C2242.4308 | CONELOG® Titanium base CAD/CAM d 4.3 mm GH 0.8 mm | K143337 |
| C2242.4320 | CONELOG® Titanium base CAD/CAM d 4.3 mm GH 2.0 mm | K143337 |
| C2242.5008 | CONELOG® Titanium base CAD/CAM d 5.0 mm GH 0.8 mm | K143337 |
| C2242.5020 | CONELOG® Titanium base CAD/CAM d 5.0 mm GH 2.0 mm | K143337 |
| P2244.4408 | iSy® Titanium base CAD/CAM d 4.5 mm - GH 0.8 mm | K133991 |
| P2244.4420 | iSy® Titanium base CAD/CAM d 4.5 mm - GH 2.0 mm | K133991 |
| P2244.5008 | iSy® Titanium base CAD/CAM d 5.2 mm - GH 0.8 mm | K133991 |
| P2244.5020 | iSy® Titanium base CAD/CAM d 5.2 mm - GH 2.0 mm | K133991 |
Non-clinical performance testing:
Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: Flexural Strength, Water sorption, Solubility, Flexural modulus, and Ball indentation hardness according to EN 1641:2009. The subject device was tested in direct comparison to the predicate device and the results of the bench testing show the products to be substantially equivalent.
All other applicable non-clinical testing, including sterilization, is leveraged from the listed predicate/reference devices.
Biocompatibility:
The subject device leveraged information previously submitted in Telio CAD Abutment Solutions (K151564) submission to show the substantially equivalent biocompatibility of the device.
24
Image /page/24/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green. The words "Ivoclar Vivadent" are in blue, with the first letter of each word capitalized. Above the words are a series of green and blue dots and squares. Below the words is the phrase "passion vision innovation" in red.
Technoloqical Characteristics:
The device design, i.e. delivery form and composition of Telio CAD Abutment Solutions- extra svstems and the predicate device are the same. The indications for use of the Telio CAD Abutment Solutions have been modified relative to the expansion of implant systems to which the existing TiBase component offerings are compatible (i.e., the addition of AstraTech Osseospeed, Frialit/Xive, Internal connection, Replace, Nobel Active, Brånemark®, Bone Level NC, Tissue Level, Tapered Screw-Vent, Camlog, and Osstem TS)
In addition, the format of the listing of all compatible implant systems in the indications for use has been modified in this premarket notification to provide further detailed information regarding the specific implant system names, implant platform size, and diameter for each of the compatible implant systems. This clarification to the compatibility list has been made for clear identification of compatible implant systems.
Testing Summary:
The device was designed and tested in accordance with quidance document for Root Form Endosseous Dental Implants and Abutments, May 12, 2004 and with ISO 14801:2007 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. This standard is recognized by the FDA under Recognition Number 4-195. All other applicable non-clinical testing is leveraged from the listed predicate/reference devices.
Conclusion:
Telio CAD Abutment Solutions- extra systems is substantially equivalent to the predicate device.