(122 days)
No
The device description and performance studies focus on the physical characteristics and sterilization/biocompatibility of a dental implant abutment, with no mention of AI or ML.
No
This device, the VARIOflex/VARIOtemp abutment, is intended to support crowns, bridges, and overdentures in conjunction with dental implants, rather than directly treating a disease or condition. It serves as a mechanical component in a restorative dental procedure.
No
Explanation: The device, VARIOunite, is described as a dental implant abutment intended to provide support for crowns, bridges, and overdentures. Its function is structural and restorative, not diagnostic. There is no mention of it being used to detect, diagnose, treat, or prevent a disease or condition.
No
The device description clearly states it is a "straight titanium dental implant abutment," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutments are used to provide support for dental restorations (crowns, bridges, overdentures) in the maxillary and/or mandibular arch. This is a mechanical function within the body.
- Device Description: The description details a physical dental implant abutment made of titanium, designed for mechanical connection to a dental implant and support of a restoration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a structural component of a dental restoration system.
N/A
Intended Use / Indications for Use
VARIOflex
Thommen Medical VARIOflex Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
VARIOtemp
Thommen Medical VARIOtemp Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
Product codes
NHA
Device Description
VARIOunite is a straight titanium dental implant abutment with retention groves that can be used for either permanent or temporary screw-retained or cement-retained restorations. Labeled as VARIOflex, it is provided with a burn-out sleeve for fabrication of a permanent restoration. Labeled as VARIOtemp, it is provided with a fabrication screw for fabrication of a temporary restoration. VARIOunite can be prepared to the appropriate occlusal height prior to fabrication of the restoration using the retention rings for guidance.
VARIOunite is available with an indexed connection for crowns or a non-indexed connection for bridges. It is available in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to existing platform diameters of the Thommen System dental implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included sterilization validation according to ISO 17665-1 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO/TR 17665-2 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1, and biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Clinical data were not submitted in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2016
Thommen Medical AG % Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K160244
Trade/Device Name: VARIOunite Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 3, 2016 Received: May 4, 2016
Dear Ms. Schulz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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,
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for 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)
Device Name
VARIOunite
Indications for Use (Describe)
VARIOflex
Thommen Medical VARIOflex Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
VARIOtemp
Thommen Medical VARIOtemp Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary Thommen Medical AG VARIOunite
May 3, 2016
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Thommen Medical AG
Neckarsulmstrasse 28
2540 Grenchen, Solothurn
Switzerland | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--|
| | Telephone: | +41 61 965 90 20 | |
| | Fax: | +41 61 965 90 21 | |
| Official Contact | Daniel Snetivy, PhD
CTO | | |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130 | | |
| | Telephone: | +1 (858) 792-1235 | |
| | Fax: | +1 (858) 792-1236 | |
| | Email: | lschulz@paxmed.com
flarson@paxmed.com | |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | VARIOunite |
|---|---|
| Common Name | Dental implant abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulation | 21 CFR 872.3630, Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
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PREDICATE DEVICE
The primary predicate device is K121334, VARIOeco, Thommen Medical AG. The reference predicate device is K120414. OsseoSpeed™ Plus, Astra Tech AB.
INDICATIONS FOR USE
VARIOflex
Thommen Medical VARIOflex abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
VARIOtemp
Thommen Medical VARIOtemp abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
DEVICE DESCRIPTION
VARIOunite is a straight titanium dental implant abutment with retention groves that can be used for either permanent or temporary screw-retained or cement-retained restorations. Labeled as VARIOflex, it is provided with a burn-out sleeve for fabrication of a permanent restoration. Labeled as VARIOtemp, it is provided with a fabrication screw for fabrication of a temporary restoration. VARIOunite can be prepared to the appropriate occlusal height prior to fabrication of the restoration using the retention rings for guidance.
V ARIOunite is available with an indexed connection for crowns or a non-indexed connection for bridges. It is available in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to existing platform diameters of the Thommen System dental implants.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included sterilization validation according to ISO 17665-1 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO/TR 17665-2 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1, and biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Clinical data were not submitted in this premarket notification.
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EQUIVALENCE TO MARKETED DEVICE
A comparison of the technological characteristics of the subject device and the primary predicate device K121334 is provided in the following table.
| Subject Device | Primary Predicate Device | Reference Predicate Device | |
|---|---|---|---|
| Thommen Medical AG | |||
| VARIOunite | |||
| K160244 | Thommen Medical AG | ||
| VARIOeco | |||
| K121334 | Astra Tech AB | ||
| OsseoSpeed Plus | |||
| K120414 | |||
| Indications | |||
| for Use | VARIOflex | ||
| Thommen Medical VARIOflex | |||
| abutments are intended to be used | |||
| in conjunction with Thommen | |||
| System dental implants in the | |||
| maxillary and/or mandibular arch | |||
| to provide support for crowns, | |||
| bridges and overdentures. | |||
| VARIOtemp Thommen Medical | |||
| VARIOtemp abutments are | |||
| intended to be used in conjunction | |||
| with Thommen System dental | |||
| implants in the maxillary and/or | |||
| mandibular arch to provide support | |||
| for crowns, bridges and | |||
| overdentures. | Thommen VARIOeco dental | ||
| implant abutments are intended to | |||
| be used in conjunction with | |||
| Thommen System dental implants | |||
| in the maxillary and/or mandibular | |||
| arch to provide support for crowns, | |||
| bridges and overdentures. | Astra Tech Implant System Plus | ||
| abutments are intended to be used | |||
| in conjunction with Astra Tech | |||
| Implant System Plus in fully or | |||
| partially edentulous maxillary | |||
| and/or mandibular arches to | |||
| provide support for crowns, | |||
| bridges or overdentures. | |||
| Design | |||
| Abutment Design | Straight abutment, | ||
| prepable | Straight abutment, | ||
| non-prepable | Straight abutment, | ||
| prepable | |||
| Abutment | |||
| Diameter (mm) | 3.5, 4.0, 4.5, 5.0, 6.0 | 3.5, 4.0, 4.5, 5.0, 6.0 | 3.0, 3.6, 4.2, 4.8, 5.4 |
| Restoration | Single or multi-unit | Single or multi-unit | Single or multi-unit |
| Implant | |||
| Connection | Internal | Internal | Internal |
| Material | |||
| Abutment | CPTi | CPTi | Titanium Alloy |
The subject device VARIOunite abutment is substantially equivalent to the primary predicate, VARIOeco K121334, in basic design and function. Both are straight titanium abutments indicated for screw-retained or cement-retained prostheses, have a precision burn-out sleeve for fabrication of the permanent prosthesis, have the same implant platform diameters, attach to the same corresponding implants in the Thommen Implant System, and are for single or multi-unit restorations. When VARIOunite is provided with a fabrication screw and labeled as VARIOtemp, it is used for a direct temporary restoration where as the primary predicate
6
VARIOeco uses a separate temporary abutment. VARIOtemp is substantially equivalent to the reference predicate K120414 in abutment design and function. The subject VARIOunite abutment prepable design is substantially equivalent to the prepable design of the reference predicate K120414.
CONCLUSION
Overall, the subject device has the following similarities to the predicate devices:
- has the same intended use, ●
- uses the same operating principle,
- incorporates the same basic design, ●
- incorporates the same or very similar materials, and
- has similar packaging and is to be sterilized using the same processes.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.