K Number
K082652
Device Name
BITTAR ZIRCONIA BLOCKS
Date Cleared
2008-12-30

(109 days)

Product Code
Regulation Number
872.6660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Bittar Zirconia Blocks are indicated for use as a substructure for ceramic dental restorations. All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
Device Description
Bittar Zirconia Blocks are an all ceramic core material made of high bisque fired Zirconia Oxide (ZrO2), and are provided in either block, rod or disk shape. CAD/CAM fabrication of the core material can then be used to produce copings and / or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2 The milling and final oven hardening process (i.e., sintering) is completed by the end user.
More Information

No
The summary describes a material (zirconia blocks) used in CAD/CAM fabrication, but there is no mention of AI or ML being used in the fabrication process itself or in any other aspect of the device's function.

No
The device is a material used to create dental restorations, not a device that directly treats or prevents disease.

No
The device, Bittar Zirconia Blocks, is a material used to create dental restorations (e.g., crowns, bridges) and is not used to diagnose medical conditions or diseases. Its purpose is to provide a substructure for ceramic dental restorations.

No

The device is described as physical blocks, rods, or disks of Zirconia Oxide, which are hardware components, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for creating substructures for dental restorations, which are physical devices used in the mouth. This is a therapeutic or restorative purpose, not a diagnostic one.
  • Device Description: The device is a material (zirconia blocks) used to fabricate dental prosthetics. It is not designed to analyze biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health.
  • Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances for diagnostic purposes.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

Bittar Zirconia Blocks are indicated for use as a substructure for ceramic dental restorations.

All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.

Product codes

EIH

Device Description

Bittar Zirconia Blocks are an all ceramic core material made of high bisque fired Zirconia Oxide (ZrO2), and are provided in either block, rod or disk shape. CAD/CAM fabrication of the core material can then be used to produce copings and / or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2 The milling and final oven hardening process (i.e., sintering) is completed by the end user.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental professional

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Sagemax Z-Blank (K062695), Vita In-Cream YZ Cubes for Cerec (K022996)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 872.6660 Porcelain powder for clinical use.

(a)
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.(b)
Classification. Class II.

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SECTION 5 - 510(k) SUMMARY

Submission Correspondent

Emergo Group, Inc.

Address

1705 S. Capital of Texas Hwy Suite 500 Austin, TX 78746

Phone

(512) 327-9997

Fax

(512) 327-9998

Contact

Stuart R. Goldman

Submission Sponsor

Bittar Zirconia Block, LLC 5 Ochs Ave. Milltown, NJ 08850 Tel: 718.968.5289 Fax: 732.246.0870

Date Prepared

June 30, 2008

Trade Name

Bittar Zirconia Blocks

Classification Name

Porcelain Powder for Clinical Use

DEC 3 0 2008

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Classification Number

872.6660

Classification Panel

Dental Devices

CDRH Product Code

ElH

Regulatory Class

Class II

Device Description

Bittar Zirconia Blocks are an all ceramic core material made of high bisque fired Zirconia Oxide (ZrO2), and are provided in either block, rod or disk shape. CAD/CAM fabrication of the core material can then be used to produce copings and / or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2 The milling and final oven hardening process (i.e., sintering) is completed by the end user.

Intended Use

Bittar Zirconia Blocks are indicated for use as a substructure for ceramic dental restorations. All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.

Predicate Devices:

    1. Sagemax Z-Blank (K062695) 2. Vita In-Cream YZ Cubes for Cerec (K022996)

Safety and Effectiveness:

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics. But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

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As such, it has been shown in this 510(k) submission, that the differences between the Bittar Zirconia Blocks and the predicate devices do not raise any questions regarding their safety and effectiveness.

The Bittar Zirconia Blocks as designed and manufactured are as safe and effective as the predicate device and therefore are determined to be substantially equivalent to the referenced predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble a person with outstretched arms, symbolizing care and protection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bittar Zirconia Block, L.L.C. C/O Mr. Stuart R. Goldman Senior Consultant Emergo Group, Incorporated 1705 South Capital of Texas Highway Suite 500 Austin, Texas 78746

DEC 30 2008

Re: K082652

Trade/Device Name: Bittar Zirconia Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 12, 2008 Received: December 24, 2008

Dear Mr. Goldman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Goldman

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Thir S. Laine, D.D.S.

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Bittar Zirconia Blocks

Type / Model: BZ

Shapes: Block, Rod & Disc

Sizes: Multiple

Indications for Use:

Bittar Zirconia Blocks are indicated for use as a substructure for ceramic dental restorations.

All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

C. Lee So M. Susan Rumer, DDS

(Division Siurrom) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082652