TIGRAN PERIBRUSH

K121114 · Tigran Technologies AB · ELB · Sep 17, 2012 · Dental

Device Facts

• Record ID: K121114
• Device Name: TIGRAN PERIBRUSH
• Applicant: Tigran Technologies AB
• Product Code: ELB · Dental
• Decision Date: Sep 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Tigran™ PeriBrush™ is a rotary debridement instrument for mechanical removal of plaque, calculus, and granulation tissue from surgically exposed titanium dental implants. Device consists of pure titanium bristles and a flexible nitinol stem; connects to standard dental handpieces (ISO 1797-1 compliant). Used by dental professionals in clinical settings during peri-implantitis treatment. Rotating action cleans implant surfaces to facilitate bone regeneration and reosseointegration. Delivered sterile; single-use only.

Clinical Evidence

Bench testing and simulated clinical performance testing conducted. Biocompatibility testing per ISO 10993-5 and sterilization validation per ISO 11137 performed. No clinical trial data provided; clinical evaluation deemed device substantially equivalent based on design and performance characteristics.

Technological Characteristics

Materials: pure titanium (bristles), nitinol (stem). Form factor: rotary brush for dental handpiece (ISO 1797-1). Energy source: external dental handpiece. Sterilization: sterile, single-use. No software or electronic components.

Indications for Use

Indicated for open debridement of titanium dental implant surfaces in bone defects caused by peri-implantitis.

Regulatory Classification

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.

Predicate Devices

• Straumann® TiBrush (K111724)

Submission Summary (Full Text)

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Tigran™ PeriBrush™

2012

# 510(k) SUMMARY

#### 1. SUBMITTER INFORMATION

| Name: | Tigran Technologies AB |
|-----------------|--------------------------------------------------------|
| Address: | Medeon Science Park<br>SE-205 12 Malmö<br>Sweden |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| 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.

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# 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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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 [phone] or [phone] 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