THE INSYNC CERAMIC SYSTEM

K111743 · Jensen Industries, Inc. · EIH · Sep 14, 2011 · Dental

Device Facts

• Record ID: K111743
• Device Name: THE INSYNC CERAMIC SYSTEM
• Applicant: Jensen Industries, Inc.
• Product Code: EIH · Dental
• Decision Date: Sep 14, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.

Device Story

InSync Ceramic System comprises pressable silica-based ceramic pellets, silica-based ceramic layering porcelain, and liquids. Used by dental technicians in a laboratory setting to fabricate dental prostheses. Pellets are pressed onto zirconia frames for full ceramic crowns; layering porcelain and liquids are applied to achieve final tooth morphology and shade. System also supports building ceramic crowns and bridges on titanium and titanium alloy substructures. Final output is a custom dental prosthesis for patients with missing or damaged teeth. Clinical benefit is the restoration of dental function and aesthetics.

Clinical Evidence

Bench testing only. The device demonstrated substantial equivalence through evaluation of chemical qualities and mechanical properties in accordance with ISO 9693 and ISO 6872 standards.

Technological Characteristics

Silica-based ceramic pellets and layering porcelain. Materials comply with ISO 9693 and ISO 6872 consensus standards. System is a manual dental laboratory material set; no software, electronics, or active energy sources.

Indications for Use

Indicated for patients requiring dental prostheses for missing or damaged teeth, specifically for the fabrication of full ceramic crowns on zirconia frames or ceramic crowns and bridges on titanium/titanium alloy substructures.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

• Ceramics 2in1 (K043221)
• Willi Geller Creation CP - ZI (K070114)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Jensen Dental. The logo consists of a stylized water droplet shape on the left, followed by the word "JENSEN" in large, bold, sans-serif font. Below the word "JENSEN" is the word "DENTAL" in a smaller, simpler font.

i

1 4 2011

Section E

**510(k) SUMMARY**

| Submitted by: | Jensen Industries<br>50 Stillman Road<br>North Haven CT 06473<br>[phone] phone<br>[phone] fax<br>Contact: Gary Phelps |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | June 14, 2011 |
| Device Name: | The InSync Ceramic System |
| Common Name: | Dental Porcelain |
| Classification Name: | Porcelain powder for clinical use (21 CFR 872.6660) |
| Classification: | Class II |
| Product Code: | EIH |

Predicate Devices

| | Ceramics 2in1: 510(k) number K043221 |
|--|------------------------------------------------------|
| | Willi Geller Creation CP - ZI: 510(k) number K070114 |

Device Description

The InSync Ceramic System consists of pressable silica based ceramic pellets and silica based ceramic layering porcelain and liquids.

## Indications for use

The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.

## Comparison to predicate devices

Data has been presented to demonstrate that the respective composition, mechanical properties, chemical qualities, and the indications for use make the InSync Ceramic System substantially cquivalent to the predicate devices Willi Geller Creation CP-Zi and Ceramics 2in1porcelains The safety and effectiveness of the InSync Ceramic System, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate devices. Independantly, the InSync Ceramic System meets the applicable sections of concensus standards ISO 9693 and ISO 6872.

(3)

50 Stillman Road, North Haven, CT 06473 JENSEN DENTAL

[phone] Fax [phone] www.jensendental.com [phone]

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines that resemble snakes intertwined around a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Gary Phelps Quality Assurance Manager Jensen Industries. Incorporated 50 Stillman Road North Haven. Connecticut 06473

SEP 14 200

Re: K111743

Trade/Device Name: The InSync Ceramic System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EHH Dated: June 06, 2011 Received: June 21, 2011

Dear Mr. Phelps:

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 111 (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.

{2}------------------------------------------------

Page 2 - Mr. Phelps

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 331-542 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.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/acm115809.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.lda.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.hun.

Sincerely vours.

hh 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 Radiolo@ical Health

## Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known):

K | | 743

Device Name: The InSync Ceramic System

Indications for Use: The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rooney

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111743

Page 1 of 1

(2)