(158 days)
Not Found
No
The device description and performance studies focus on mechanical debridement and material properties, with no mention of AI or ML.
No
The device is a debridement instrument used to remove plaque and calculus from dental implants, which is a mechanical intervention rather than a therapeutic treatment itself.
No
The device is described as a 'debridement instrument' used for 'mechanical debridement' of implant surfaces. Its function is to remove plaque and calculus, not to diagnose a condition.
No
The device description explicitly states the device is made of pure titanium and nitinol, indicating it is a physical instrument, not software.
Based on the provided information, the Tigran™ PeriBrush™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the mechanical debridement of titanium dental implant surfaces in vivo (within the body) during surgery. This is a therapeutic procedure, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The device is a physical instrument used for cleaning and removing material from the implant surface. It does not involve the analysis of biological samples or the detection of substances.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting markers, or providing diagnostic information.
Therefore, the Tigran™ PeriBrush™ is a surgical instrument used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Tigran™ PeriBrush™ is intended for: Tigran™ PeriBrush™ is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium Implant surfaces in bone defects caused by peri-implantitis.
Product codes
ELB
Device Description
The Tigran™ PeriBrush™ is made of pure titanium (brush part) and nitinol (stem part). It is intended to use for mechanical debridement of surgically exposed dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis. The product has a connector that fits into the head (chuck) of a dental handpiece accepting instruments complying with ISO 1797-1. The instrument is delivered sterile. The Tigran™ PeriBrush™ is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental titanium implant surfaces
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
Mechanical tests and simulated clinical performance tests allows for mechanical surface debridement. It is reasonable to state and conclude that the preclinical tests support that Tigran™ Peribrush™, when used as intended under normal conditions, is substantially. equivalent. Biocompatibility testing was conducted in accordance with ISO 10993-5, and all materials tested met the relevant standards. Sterilization validation was conducted in accordance with ISO 11137. Clinical evaluation showed that the brush is substantially equivalent.
Key Metrics
Not Found
Predicate Device(s)
Straumann® TiBrush, K111724
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4840 Rotary scaler.
(a)
Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.(b)
Classification. Class II.
0
Tigran™ PeriBrush™
2012
510(k) SUMMARY
1. SUBMITTER INFORMATION
| Name: | Tigran Technologies AB |
|---|---|
| Address: | Medeon Science Park |
| SE-205 12 Malmö | |
| Sweden | |
| Telephone: | +46 40 6939270 |
| Facsimile: | +46 40 650 1666 |
| Contact Person: | Ulf Lundgren, Quality Assurance and Regulatory Manager |
| Date: | 12th of September 2012 |
2. DEVICE IDENTIFICATION
Trade Name: Tigran™ PeriBrush™ PeriBrush™ Common Name: Classification Name: Scaler, Rotary
3. DEVICE CLASSIFICATION
| Device Code: | Rotary Scaler, ELB |
|---|---|
| Predicate Device | Straumann® TiBrush, K111724 |
4. DEVICE DESCRIPTION
The Tigran™ PeriBrush™ is made of pure titanium (brush part) and nitinol (stem part). It is intended to use for mechanical debridement of surgically exposed dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis. The product has a connector that fits into the head (chuck) of a dental handpiece accepting instruments complying with ISO 1797-1.
The instrument is delivered sterile. The Tigran™ PeriBrush™ is for single use only.
5. INTENDED USE
Tigran™ PeriBrush™ is intended for:
Tigran™ PeriBrush™ is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium Implant surfaces in bone defects caused by peri-implantitis.
1
6. SUBSTANTIAL EQUIVALENCE
In summary, Tigran™ PeriBrush™, is substantially equivalent to the cited predicate device, Straumann® TiBrush, K111724.
They have the same intended use designed for mechanical debridement of dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis.
- . Straumann® TiBrush, K111724
7. TECHNOLOGICAL CHARACTERISTICS
Tigran™ PeriBrush™, is substantially equivalent to the cited predicate device. Following bone loss caused by peri-implantitis, parts of the implant surface becomes exposed to the oral microflora. Before steps towards regenerating the lost bone and reosseointegration of the implant can be taken, the exposed implant surface must be clean from any contamination that could hamper the treatment outcome. This means that the granulation tissue, calculus and/or other macrostructures like excess cementum must be removed.
The device removes contaminants from the surface of the implants. The rotating Tigran™ PeriBrush™ with stiff titanium bristles and flexible stem.
8. PERFORMANCE TESTING
Mechanical tests and simulated clinical performance tests allows for mechanical surface debridement. It is reasonable to state and conclude that the preclinical tests support that Tigran™ Peribrush™, when used as intended under normal conditions, is substantially . equivalent.
Biocompatibility testing was conducted in accordance with ISO 10993-5, and all materials tested met the relevant standards.
Sterilization validation was conducted in accordance with ISO 11137.
Clinical evaluation showed that the brush is substantially equivalent.
9. CONCLUSION
The results from the testing conducted demonstrated that the Tigran™ PeriBrush™ functions as intended and is substantially equivalent.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of an eagle or bird-like figure with three swooping lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tigran Technologies AB
Mr. Ulf Lundgren
Quality Assurance and Regulatory Manager
Medeon Science Park
SE-205 12 Malmö, Sweden
SEP 17 2012
Re: K121114
Trade/Device Name: TigranTM PeriBrushTM Regulation Number: 21 CFR 872.4840 Regulation Name: Rotary Scaler Regulatory Class: II Product Code: ELB Dated: August 21, 2012 Received: August 24, 2012
Dear Mr. Lundgren:
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. e 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.
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Page 2- Mr. Lundgren
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Tigran™ PeriBrush™
Indications for Use:
Tigran™ PeriBrush™ is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium Implant surfaces in bone defects caused by peri-implantitis.
| Prescription Use | X | And/Or | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K122114
2012-03 Concurrence of CDRH, Office of Device Evaluation (ODE) 4-2