(103 days)
No
The summary describes a CAD/CAM system for fabricating temporary dental restorations using resin blocks and a Ti base. While it uses CAD/CAM technology, there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on material properties and mechanical performance.
Yes
The device is intended for temporary restoration of single hybrid abutment crowns, used in conjunction with dental implants. Its function of providing a temporary dental restoration is a therapeutic purpose.
No
The device is a temporary restoration (hybrid abutment crowns) for dental implants, not a tool used for diagnosis. Its purpose is to physically replace missing dental structures temporarily.
No
The device description clearly states it is a resin block (PMMA) and mentions physical testing (flexural strength, hardness, fatigue, biocompatibility), indicating it is a physical material/device, not solely software. While CAD/CAM software is mentioned as part of the system, the device itself is the physical resin block.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "single hybrid abutment crowns for temporary restoration" and is "cemented to the Ti base and used in conjunction with endosseous dental implants." This describes a device used in vivo (within the body) for structural support and restoration, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a "resin block" that is "milled using CAD/CAM Technology then cemented to the Sirona Ti base and used for the purpose of temporary hybrid abutment crowns." This further reinforces its use as a physical component for dental restoration.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
- Performance Studies: The performance studies focus on mechanical properties (flexural strength, hardness, fatigue) and biocompatibility, which are relevant for a device used in vivo for structural purposes, not for an IVD.
In summary, the device is a dental prosthetic component used for temporary restoration in conjunction with dental implants, which falls under the category of a medical device used in vivo, not an IVD.
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 Solution -
- 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 Implant (K053088), Biomed 3i Certain (K014235)
CAD/CAM Systems: Sirona inLab and CEREC SW 4.2 and above
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Telio CAD Abutment Solutions are resin blocks with an interface hole in Small and large sizes to accommodate Sirona Ti bases (K100152 and K111421) in the fabrication of temporary hybrid abutment crowns. The Device is milled using CAD/CAM Technology then cemented to the Sirona Ti base and used for the purpose of temporary hybrid abutment crowns in coniunction with endosseous dental implants. Hybrid abutment crowns are characterized by combining a Ti base and monolithic crown in one piece.
Telio® CAD Abutment Solutions are CAD/CAM-fabricated implant-supported hybrid restorations for individual, temporary single-tooth reconstructions. The material consists of a cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base. Shape, esthetics and emergence profile can be easily designed and adjusted any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing Summary:
- (a) The device has been tested for flexural strength. Flexural modulus. Water absorption and Solubility according to EN ISO 10477:2004 Dentistry - Polymer based crown and bridge materials and the results are comparable to the predicate Device TelioCAD.
- (b) An internal Ball Hardness test was also conducted and showed comparable results with the predicate.
- (c) Dynamic fatigue testing for these implant systems (worst case) with Telio CAD Abutment Solutions has been carried out according to EN ISO 14801:2007 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants (ISO 14801:2007) and shows the performance to be suitable for use as a temporary abutment and comparable to the predicate device.
- (d) Biocompatibility testing and evaluation was also carried out according to ISO 10993-1 and ISO 7504.
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.
IPS e.max CAD Abutment Solutions (K132209), Straumann CARES Variobase Temporary Abutments (K120822), Telio CAD (K093708)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a stylized eagle above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21,2015
Ivoclar Vivadent Ag % Donna Hartnett Director OA/Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228
Re: K151564
Trade/Device Name: Telio CAD Abutment Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 19, 2015 Received: August 20, 2015
Dear Ms. Hartnett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151564
Device Name
Telio CAD Abutment Solutions
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 Solution
-
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 system, CAD/CAM Systems and Ti bases arc shown below:
Implant Systems: Straumann Bone Level Implant (K0530g8), Biomed 3i Certain (K014235)
CAD/CAM System & Software: Sirona inLab and CEREC SW 4.2 and above (K100152 and K111421).
| Titanium bases (K100152 and K111421): | |||||
|---|---|---|---|---|---|
| Implant Manufacturer | Implant System | Implant Diameter | TiBase | Sirona Ref | Interface Size |
| Straumann | Bone Level RC | 4.1/4.8 | S BL 4.1 | 6308337 | L |
| Biomct 3i | Certain | 3.4 | BC 3.4 | 6308048 | S |
| Certain | 4.1 | BC 4.1 | 6308097 | L | |
| Certain | 5.0 | DC 5.0 | 6308121 | L |
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.
3
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4
510(K) SUMMARY Rev 8.19.2015 Telio CAD Abutment Solutions
Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in blue and green, with the words "passion vision innovation" written in a smaller font below. Above the company name are several green and blue circles and squares. The logo is simple and modern, and it conveys a sense of professionalism and innovation.
Contact: Donna Marie Hartnett
| Company: | Ivoclar Vivadent, AG |
|---|---|
| Bendererstrasse 2, Schaan, FL-9494, Liechtenstein | |
| +423-235-3535 | |
| Date Prepared: | August 19, 2015 |
| Proprietary Name: | Telio CAD Abutment Solutions |
| Classification Name: | Abutment, Implant dental endosseous (872.3630) |
| (Classification Code NHA) | |
| Predicate Device: | IPS e.max CAD Abutment Solutions (K132209) |
| Straumann CARES Variobase Temporary Abutments (K120822) | |
| Telio CAD (K093708) |
Device Description: Telio CAD Abutment Solutions are resin blocks with an interface hole in Small and large sizes to accommodate Sirona Ti bases (K100152 and K111421) in the fabrication of temporary hybrid abutment crowns. The Device is milled using CAD/CAM Technology then cemented to the Sirona Ti base and used for the purpose of temporary hybrid abutment crowns in coniunction with endosseous dental implants. Hybrid abutment crowns are characterized by combining a Ti base and monolithic crown in one piece.
Telio® CAD Abutment Solutions are CAD/CAM-fabricated implant-supported hybrid restorations for individual, temporary single-tooth reconstructions. The material consists of a cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base. Shape, esthetics and emergence profile can be easily designed and adjusted any time.
Intended 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 Solution -
- 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 Implant (K053088), Biomed 3i Certain (K014235)
CAD/CAM Systems: Sirona inLab and CEREC SW 4.2 and above
5
510(K) SUMMARY Rev 8.19.2015 Telio CAD Abutment Solutions
Image /page/5/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green. The word "ivoclar" is in blue, and the word "vivadent" is in blue below it. Above the words are a series of green and blue dots and squares arranged in an arc.
passion vision innovation
| 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 |
| Biomet 3i | Certain | 3.4 | BC 3.4 | 6308048 | S |
| | | 4.1 | BC 4.1 | 6308097 | L |
| | | 5.0 | BC 5.0 | 6308121 | L |
Titanium bases (K100152 and K111421):
Technological Characteristics: Telio CAD Abutment Solutions is a PMMA temporary restorative material (for periods up to 12 months) used with the Sirona Ti base. The device is currently indicated for use with a limited range of implant systems. Telio CAD Abutment Solutions is currently also limited to hybrid abutment crowns (i.e. top half of abutment mixed with full crown over Ti base abutment bottom-half). The contraindications are consistent with those of IPS e.max CAD Abutment Solutions and reflect the temporary usage of Telio CAD Abutment Solutions.
Specific design parameters for optimum performance are recommended. These are compared with those of the predicate device Straumann CARES Variobase Temporary Abutments (also a PMMA material). The following minimum thicknesses are defined for the hybrid abutment crown restoration:
Occlusal: minimum 1.5 mm Circular: minimum 0.8 mm in the transition area to the Ti base rim: minimum 0.5 mm Maximum angle 20º
The width of the hybrid abutment crown is limited to 6.0 mm from the axial height of contour to the screw channel. Depending on the dimensions of the Ti base interface (S or L) the block is selected to match. The recommendations of the implant manufacturer regarding maximum height must be observed.
Concerning the recommended sterilization procedure these are the same as the previously cleared predicate Straumann CARES Variobase Temporary Abutments, which is also a PMMA temporary abutment material.
Testing Summary:
- (a) The device has been tested for flexural strength. Flexural modulus. Water absorption and Solubility according to EN ISO 10477:2004 Dentistry - Polymer based crown and bridge materials and the results are comparable to the predicate Device TelioCAD.
- (b) An internal Ball Hardness test was also conducted and showed comparable results with the predicate.
- (c) Dynamic fatigue testing for these implant systems (worst case) with Telio CAD Abutment Solutions has been carried out according to EN ISO 14801:2007 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants (ISO 14801:2007) and shows the performance to be suitable for use as a temporary abutment and comparable to the predicate device.
- (d) Biocompatibility testing and evaluation was also carried out according to ISO 10993-1 and ISO 7504.
6
510(K) SUMMARY
Image /page/6/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green. The word "ivoclar" is on top of the word "vivadent". Above the words are a series of green and blue circles and squares.
passion vision innovation
| Summary Substantial Equivalence compared to Predicate Device | ||||
|---|---|---|---|---|
| Device Name | Telio CAD Abutment | |||
| Solutions K151564 | Primary predicate: | |||
| IPS e.max CAD | ||||
| Abutment Solutions | ||||
| K132209 | Straumann | |||
| CARES | ||||
| Variobase | ||||
| Temporary | ||||
| abutments | ||||
| K120822 | Telio CAD | |||
| K093708 | ||||
| Company Name | Ivoclar Vivadent AG | Ivoclar Vivadent AG | Straumann | Ivoclar Vivadent |
| AG | ||||
| 510(k) No. | K151564 | K132209 | K120822 | K093708 |
| Product Code | NHA | NHA | NHA | EBG |
| Compatible Implant | ||||
| Types | St Bone Level RC | |||
| 4.1,4.8 (K053088) | ||||
| Biomet Certain 3.4 | ||||
| Biomet Certain 4.1 | ||||
| Biomet Certain 5.0 | ||||
| (K014235) | NB Replace NP 3.5 | |||
| NB Replace RP 4.3 | ||||
| NB Replace WP 5.0 | ||||
| NB Replace 6.0 | ||||
| NB Active NP 3.5 | ||||
| NB Active RP 4.3,5.0 | ||||
| St Bone Level NC 3.3 | ||||
| St Bone Level RC | ||||
| 4.1,4.8 | ||||
| Biomet Certain 3.4 | ||||
| Biomet Certain 4.1 | ||||
| Biomet Certain 5.0 | Straumann NNC, | |||
| RN, WN, NC, RC | Not relevant | |||
| Indications for Use | ||||
| or Intended use | Single hybrid abutment | |||
| crowns for temporary | ||||
| restoration (up to 12 | ||||
| months) | In partially or fully | |||
| edentulous mandibles | ||||
| and maxillae in support | ||||
| of single cement- | ||||
| retained restorations. | Temporary | |||
| restoration (up to | ||||
| 180 days) of a | ||||
| Straumann dental | ||||
| implant | For temporary | |||
| crowns and | ||||
| bridges | ||||
| Custom Design | ||||
| Maximal abutment | ||||
| angulation | 20° | 20° | No information | Not relevant |
| Abutment diameter | Limited by oral situation. | |||
| Max width is limited to | ||||
| 6mm from axial height | ||||
| of contour to the screw | ||||
| channel | Limited by oral situation. | |||
| Max width is limited to | ||||
| 6mm from axial height | ||||
| of contour to the screw | ||||
| channel | No information | Not relevant | ||
| Abutment height | Follow recommendation | |||
| of implant manufacturer | Follow recommendation | |||
| of implant manufacturer | No information | Not relevant | ||
| Retention | Abutment parts luted | |||
| with self-curing luting | ||||
| composite | Abutment parts luted | |||
| with self-curing luting | ||||
| composite | Coping cemented | |||
| to abutment | Restoration | |||
| luted with dual | ||||
| cure temporary | ||||
| luting composite | ||||
| to core | ||||
| Abutment fixation | Screwed | Screwed | Screwed | Not relevant |
| 1 or 2 piece | ||||
| abutment | 2 piece: Telio CAD with | |||
| TiBase | 2 piece: IPS e.max CAD | |||
| with TiBase | 2 piece: coping | |||
| with abutment | Not relevant | |||
| CAD/CAM | ||||
| processing | TelioCAD milled with | |||
| Sirona CEREC/inLab | ||||
| TiBase milled in | ||||
| manufacturer's | ||||
| production facility | IPS e.max CAD milled | |||
| with Sirona | ||||
| CEREC/inLab | ||||
| TiBase milled in | ||||
| manufacturer's | ||||
| production facility | Straumann | |||
| CARES Scan, | ||||
| Straumann milling | ||||
| centre | Sirona | |||
| CEREC/inLab, | ||||
| PlanMill | ||||
| Device Name | Telio CAD Abutment | |||
| Solutions K151564 | Primary predicate: | |||
| IPS e.max CAD | ||||
| Abutment Solutions | ||||
| K132209 | Straumann | |||
| CARES | ||||
| Variobase | ||||
| Temporary | ||||
| abutments | ||||
| K120822 | Telio CAD | |||
| K093708 | ||||
| Material | ||||
| Abutment | Metal Base titanium | |||
| Coping - PMMA | ||||
| Screw - Titanium | Metal Base - titanium | |||
| Coping - Ceramic | ||||
| Screw - Titanium | PMMA + titanium- | |||
| aluminium- | ||||
| niobium alloy | Not relevant | |||
| Screw | Part of implant system | Part of implant system | Titanium- | |
| aluminium- | ||||
| niobium | Not relevant | |||
| Mechanical Testing | Dynamic fatigue testing. | Dynamic fatigue | ||
| testing. | Dynamic fatigue | |||
| testing. The test | ||||
| specimens | ||||
| passed the | ||||
| predefined | ||||
| acceptance | ||||
| criteria. | Physical | |||
| property testing. | ||||
| The test | ||||
| specimens pass | ||||
| the predefined | ||||
| acceptance | ||||
| criteria. | ||||
| Sterile | No | No | No | No |
| Reusable | No | No | No | No |
| Principles of | ||||
| Operation (for the | ||||
| Dentist/Technician) | Scanning | |||
| Designing | ||||
| Milling | ||||
| Luting | ||||
| Finishing | Scanning | |||
| Designing | ||||
| Milling | ||||
| Luting | ||||
| Finishing | Scanning | |||
| Designing | ||||
| Screwing. | ||||
| Milling, luting and | ||||
| finishing provided | Scanning | |||
| Designing | ||||
| Milling | ||||
| Finishing | ||||
| Temporary |
7
510(K) SUMMARY Rev 8.19.2015 Telio CAD Abutment Solutions
Image /page/7/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green. The word "ivoclar" is in blue, and the word "vivadent" is in blue below it. Above the words are a series of green and blue dots and squares.
passion vision innovation
CONCLUSION: Telio CAD Abutment Solutions is a variation on the previously cleared predicate Telio CAD. Telio CAD Abutment Solutions is used as a temporary hybrid abutment crown in conjunction with the Sirona Ti base which can later be permanently restored using IPS e.max CAD Abutment Solutions. The subject device differs from the primary predicate device KK132209 in that the primary predicate is a permanent abutment. This difference is addressed by use of a reference predicate K120822 which is also a temporary abutment device. The subject device also is intended for use up to 12 months, while the reference predicate K120882 is intended for use up to 6 months; the sponsor performed additional and extensive testing to support the additional 6 months temporary use of the subject device. The documentation show that Telio CAD Abutment Solutions is substantially equivalent to the predicate devices, IPS e.max CAD Abutment Solutions, Straumann CARES Variobase Temporary Abutments and Telio CAD.