(151 days)
Not Found
No
The document describes preformed plastic denture teeth and does not mention any AI or ML capabilities.
No
Explanation: This device is a preformed plastic denture tooth used for veneering and temporary restorations. While it is a medical device, its function is primarily restorative and aesthetic, not therapeutic (treating a disease or health problem). The provided information does not indicate it delivers any therapeutic effect such as drug delivery, pain relief, or treating a condition.
No
The device is described as preformed plastic denture teeth intended for use as veneers for dental restorations, not for diagnosing conditions. Its purpose is to replace or restore teeth, which is a therapeutic rather than a diagnostic function.
No
The device is described as preformed plastic denture teeth made of polymethylmethacrylate and methylmethacrylate, which are physical materials, not software. The description focuses on their chemical properties and use in fabricating dental restorations.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the bredent novo.lign A / novo.lign P are "preformed plastic denture teeth" used as "veneers" for various dental restorations (dentures, crowns, bridges, etc.). This is a restorative dental device, not a diagnostic one.
- Device Description: The description reinforces that these are "multi-layer veneers for anterior and posterior teeth" used in "fabricating any kind of dental restauration."
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility and compliance with standards related to artificial teeth, not on diagnostic accuracy or performance.
In summary, the bredent novo.lign A / novo.lign P are materials used to construct or repair dental structures within the mouth. This falls under the category of a medical device, specifically a dental prosthetic or restorative device, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novo:lign P are used for temporary or partial or full dentures.
Permanent veneering:
- telescopic and conical crowns
- CoCr clasp restorations
- crowns and bridges
- implant-supported restorations
- coverdenture techniques
Veneer-up:
- selection of esthetic shade, shape and tooth position
Temporary restorations:
- laboratory-made temporaries based on impression and wax-up
- veneer on temporary abutments after placement of the implant
The devices are offered in non-sterile condition.
Product codes (comma separated list FDA assigned to the subject device)
ELM
Device Description
Bredent novo.lign A / novo.lign P artificial are multi-layer veneers for anterior and posterior teeth. Theses teeth devices are chemically based on polymethacrylate-polymers and their chemical properties. These reformed plastic dentures are used when fabricating any kind of dental restauration (see application range beneath).
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
Not Found
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)
Non-clinical performance data:
Bredent certifies compliance with the requirements of the following device relevant standards: ISO 7405 "Deatisty - Evaluation of biocompatibility of medical devices used in dentistry", ADA / ANSI ADA Specification No.15 " Synthetic Polymer Teeth", and ISO 22112 "Dentistry - Artificial teeth for dental Specification No.15 - Synthele Polyment of the directive 93/42/EEC have been performed on the bredent novo.lign A / novo.lign P devices. .
Summary:
The presented data that was conducted on the bredent products shows in its results and in rile presenced that the needicate device that the products perform as well as or better than the companison to the predicate device for their intended use and do not raise any questions predice device, but affectiveness. All models that are covered by this 510(k) premarket regarding salecy and Creetiveness. An Europe for many years with no device failures. The nouncation have been one med and do not raise any kind of question regarding safety and effectiveness of the finished product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Dote: 03/15/10
bredent
510(k) Summary as required by section 807.92(c)
Submission Applicant: bredent GmbH & Co. KG Weissenhorner Str. 2 89250 Senden Phone: (xx49 ) 73 09 87 2 - 440 Fax: (xx49 ) 73 09 87 2 - 444 E-mail: info-lab@bredent.com
SEP 1 4 2010
Establishment Registration Number: 1000303432
Application correspondent/Contact person: Andrea Pecsi Think! Schwarzwaldstrasse 5 78532 Tuttlingen Phone: (xx49 ) 74 62 92 40 51 Fax: (xx49) 74 62 92 41 28 E-mail: andrea@thinkworks.biz
Trade name: K101064 - bredent novo.lign A / novo.lign P
Common name: Preformed plastic tooth / artificial PMMA teeth
Classfication name: Preformed plastic denture tooth, Dental (21 CFR 872.3590 - ELM)
Predicate Device: K962456 – SR Antaris anterior teeth/SR Postaris posterior teeth
Description of the Device:
Bredent novo.lign A / novo.lign P artificial are multi-layer veneers for anterior and posterior teeth. Theses teeth devices are chemically based on polymethacrylate-polymers and their chemical properties. These reformed plastic dentures are used when fabricating any kind of dental restauration (see application range beneath).
Indications for Use:
The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, rne bread.net november 11, hous polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novo.lign P are used for temporary or partial or full dentures.
1
>510(k) Summary
bredent
Permanent veneering:
- · telescopic and conical crowns
- · CoCr clasp restorations
- · crowns and bridges
- · implant-supported restorations
- · coverdenture techniques
Veneer-up:
- · selection of esthetic shade, shape and tooth position
Temporary restorations:
- · laboratory-made temporaries based on impression and wax-up
- · veneer on temporary abutments after placement of the implant
The devices are offered in non-sterile condition.
Technological characteristics compared to the Predicate Device
The bredent product is similiar to the predicate device in terms of technical characteristics, design, Indications for Use, target population, where it is used, performance, biocompatibility characteristics as well as sizes and configurations. Therefore the bredent product can be deemed substantially equivalent and safe and effective for its indicated use.
Non-clinical performance data
Bredent certifies compliance with the requirements of the following device relevant standards: ISO 7405 "Deatisty - Evaluation of biocompatibility of medical devices used in dentistry", ADA / ANSI ADA Specification No.15 " Synthetic Polymer Teeth", and ISO 22112 "Dentistry - Artificial teeth for dental Specification No.15 - Synthele Polyment of the directive 93/42/EEC have been performed on the bredent novo.lign A / novo.lign P devices. .
Summary
The presented data that was conducted on the bredent products shows in its results and in rile presenced that the needicate device that the products perform as well as or better than the companison to the predicate device for their intended use and do not raise any questions predice device, but affectiveness. All models that are covered by this 510(k) premarket regarding salecy and Creetiveness. An Europe for many years with no device failures. The nouncation have been one med and do not raise any kind of question regarding safety and effectiveness of the finished product.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bredent GmbH & Company KG C/O Ms. Andrea Pecsi Regulatory Affairs Specialist Think! Schwarzwald Strasse 5 D-78532 Tuttlingen, BaWü Germany
1 4 2010
Re: K101064
Trade/Device Name: Bredent novo.lign A / novo.lign P Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: August 4, 2010 Received: August 18, 2010
Dear Ms. Pecsi:
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 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.
3
Page 2 - Ms. Pecsi
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh 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
4
Indication for Use
510(k) Number: K101064
Device Name: bredent novo.lign A / novo.lign P
Indications for use:
The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novo:lign P are used for temporary or partial or full dentures.
Permanent veneering:
- · telescopic and conical crowns
- · CoCr clasp restorations
- · crowns and bridges
- · implant-supported restorations
- · coverdenture techniques
Veneer-up:
· selection of esthetic shade, shape and tooth position
Temporary restorations:
· laboratory-made temporaries based on impression and wax-up
- · veneer on temporary abutments after placement of the implant
The devices are offered in non-sterile condition.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of DCRH, Office of Device Evaluation (ODE)
Page 01 of 01
Susan Russo
(Division Sign-Off) (Division Sign-Oit)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Infection Control, Dental Devices
510(k) Number: K101064