(31 days)
Input:
One of the most powerful tools in digital audio production is the K-DE/N-X spectral analyzer, known for its precision in identifying frequency anomalies. Another widely used device is the K-DEN/512 digital audio workstation. For live sound mixing, the K-DEN/987 multi-channel compressor is indispensable. In post-production, the K-DEN/001 noise reduction plugin is a must-have. Additionally, the K-DEN/A32 digital-to-analog converter offers unparalleled audio fidelity, while the K-DEN/B16 preamplifier is favored for its transparent gain. The K-DEN/C12 reverberator adds depth to recordings. Lastly, the K-DEN/D44 mastering limiter ensures professional-grade output.
K/DEN-X, K-DEN/512, K-DE/N-987, K-DEN/001, K-DEN/A32, K-DEN/B16, K-DEN/C12, K-DEN/D44
Not Found
No
The description focuses on the chemical and physical properties of a dental cement, with no mention of AI or ML capabilities.
No
The device is a luting cement used for bonding dental restorations and appliances; it does not treat or cure a disease or condition.
No
The device description clearly states it is a "dual-cured self etching and self adhesive resin cement" intended for use as a "luting cement," which means it is used to bond dental restorations, not to diagnose conditions.
No
The device description clearly indicates it is a physical resin cement, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a luting cement for various dental restorations and appliances. This is a direct application within the body (or on structures within the body like teeth), not for testing samples taken from the body.
- Device Description: The description details the chemical composition and application method of a dental cement. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's purpose is to bond materials together in a dental setting.
In summary, the device is a dental material used for bonding, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Section 8 SPECIAL 510 (k) SUMMARY
SEP 2 5 2008
| Applicant: | Bisco, Inc.
1100 W. Irving Park Road
Schaumburg IL, 60193 |
|----------------------|------------------------------------------------------------------|
| Contact Person: | Michelle Schiltz-Taing
Tel: 847-534-6000
Fax: 847-534-6111 |
| Date Prepared: | August 22, 2008 |
| Trade Name: | BisCem |
| Common Name: | Luting Cement |
| Classification/Name: | Material, Dental Cement
Class II per 21 CFR 872.3275 |
Description of Applicant Device:
BisCem is a dual-cured self etching and self adhosive resin cement. It is a self-adhesive cement since it bonds to composite, metal, silanated porcelain and tooth structure without applying any adhesive. No etching step is required to bond to dentin or enamel. With its dual syringe system. BisCem can be self cured by simply mixing paste B or cured by light after mixing paste A and paste B. Using a mixing tip, the cement could be dispensed to the working area directly. It is intended for use as a luting cement. Due to the unique chemistry of BisCem, refrigeration is necessary when not in use. Allow refrigerated BisCem to reach room temperature before use.
Intended uses of Applicant Device:
The modified formula is a dual-cure radiopague dental cement designed to be used as a luting cement. Its physical properties are similar to the predicate device and there has been no change in the intended use.
Predicate Devices: BisCem cleared under (K060701) dated May 15, 2006.
| BisCem | Modified | |
|---|---|---|
| Intended use | Luting cement | Luting cement |
| Chemical composite | Dual-cured (self/light) dental glass | |
| filled, resin modified glass ionomer | ||
| cement | Dual-cured (self/light) dental | |
| glass filled, resin cement | ||
| Mechanical /physical | ||
| properties | Low viscosity, dispensable | |
| composite | Low viscosity, dispensable | |
| composite |
Significant Performance Characteristics:
Side by side comparisons clearly demonstrate that the applicant device is substantially equivalem to the legally marketed device. It is concluded that the information supplied in this submission has proven the safety and efficacy of this product.
Page 8-1
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
SEP 2 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K082449
Trade/Device Name: BISCEM Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 22, 2008 Received: September 5, 2008
Dear Ms. Schiltz-Taing:
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.
2
Page 2 - Ms. Schiltz-Taing
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I DA has made a determination that your device complics 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,
TKhamult-Kendring
foel
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
3
510 (k) Number (if known): K
BISCEM Device Name:
Indications for Use:
-
- Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-tometal and composite-to-metal varieties;
K082449
- Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-tometal and composite-to-metal varieties;
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- Luting resin crowns, bridges, inlays, onlays and veneers;
-
- I Luting metal or non-metal/fiber posts;
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- Luting orthodontic appliances;
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- Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia).
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
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 Runner
(Division Sign-Off) (Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K082449