(63 days)
NaturaZ Series is used in the manufacture of dental prosthetics. The Dental Solution, Inc. proposes that the materials distributed within the United States be labeled: 'CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."
NaturaZ Series is a pre-formed material for use by dental laboratories. NaturaZ Series is used in the manufacture of dental prosthetics.
The NaturaZ Series is a pre-formed material for use in the manufacture of dental prosthetics. This 510(k) summary indicates that no performance data was required to demonstrate substantial equivalence to a predicate device (KaVo Everest® ZS-Blank K032081). The claim of substantial equivalence is based on comparisons of formulations and intended uses.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from the provided text, as no such study was conducted or required.
Here's a breakdown of why each section of your request cannot be fulfilled based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted: The document explicitly states "PERFORMANCE DATA: Non Required." and bases its clearance on equivalence to a predicate device via formulation and intended use comparison, not on meeting specific performance criteria demonstrated through testing.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted: No performance study with a test set was conducted or required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be extracted: No test set or ground truth establishment was performed, as no performance study was required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted: No test set or adjudication method was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be extracted: This device is a material for dental prosthetics, not an AI or imaging device, so an MRMC study is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted: This device is a material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be extracted: No ground truth was established, as no performance study was conducted.
8. The sample size for the training set
- Cannot be extracted: This device is a material, not a machine learning model; therefore, no training set was used.
9. How the ground truth for the training set was established
- Cannot be extracted: No training set or ground truth for a training set was established.
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K09/096
510(K) SUMMARY NaturaZ Series
JUN 18 2009
This 510(k) summary of safety and effectiveness for NaturaZ Series (B16, B20,
11 CFR This 510(k) summary of safety and ellectivel.ose for Natures in National Part 21 CFR
B42, B60, B98, B100) material is submitted in accordance under Part 21 CFR 807.92.
The Dental Solution, Inc. APPLICANT:
Geum Cheon Gu, Ga San Dong, 371-36 ADDRESS: 4th Floor S&T Building Seoul, Korea 153-803
MANUFACTURER: DMAX Co., LTD DMAX OS:, EFB
Geum Cheon Gu, Ga San Dong, 371-36 4th Floor S&T Building Seoul, Korea 153-803
CONTACT PERSON: Andrew Paeng, Consultant
(310) 858-2900, FAX (615) 712-7724 TELEPHONE:
naturaz series (B16, B20, B42, B60, B98, B100) DEVICE NAME:
COMMON NAME: Porcelain, Powder for clinical use
- CLASSIFICATION: Porcelain, Porcelain, Powder for clinical use 21 CFR 872.6660 Class II Product Code: EIH Panel: 76 (Dental)
PREDICATE DEVICE: KaVo Everest® ZS-Blank K032081
DEVICE DESCRIPTION:
lON:
NaturaZ Series is a pre-formed material for use by dental labo-NaturaZ Senes is a pre-formou material prosthetics
- NaturaZ Series is used inthe manufacture of dental prosthetics. NaturaZ Series is used intrie manufacture of the materials distributed.
The Dental Solution, Inc. proposes that the materials distributed. INDICATION: The Dental Solation of States be labeled:
"CAUTION: Federal (US) law restricts the sale of this device to, "
"CAUTION: Federal (US) law restricts " CAOTION: Pedoral (onsed professionals."
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510(K) SUMMARY NaturaZ Series (B16, B20, B42, B60, B98, B100)
(Page 2 of 2)
PERFORMANCE DATA: Non Required. The claim of substantial equivalence is
t the productions from the productions and intended uses of the predicate device, PERFORMANCE DATA: Non Required: The claim of ourselands of the predicate device,
based on comparisons of formulations and intended uses of the predicate device, KaVo Everest ZS-Blank.
CONCLUSION: There are no significant differences between the NaturaZ Series are equally safe and effective CONCLUSION: There are no significant uniterenoos betwoon in and effective
and the predicate device. Therefore, NatureZ Series are equally safe and effective
France and the and the predicate device, KaVo Everest ZS--Blank.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three wing-like shapes extending to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.
Public Health Service
JUN 18 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Dental Solution, Incorporated C/O Mr. Andrew Paeng Consultant The Dental Solution America, Incorporated 9301 Wilshire Boulevard PH5 Beverly Hills, California 90210
Re: K091096
Trade/Device Name: NaturaZ Series B16, B20, B42, B60, B98, B100 Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: ETH Dated: April 15, 2009 Received: April 16, 2009
Dear Mr. Paeng:
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 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. Paeng
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sheon Rumper
Susan Runner, D.D.S., M.A. Acting 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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INDICATION OF USE
510(k) Number:
DEVICE NAME: NaturaZ Series B16, B20, B42, B60, B98, B100
INDICATION FOR USE: NaturaZ Series is used in the manufacture of dental prosthetics. The Dental Solution, Inc. proposes that the materials distributed within the United States be labeled:
'CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."
Prescription Use (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)
Kei Wuley for MSE
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091091
§ 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.