(88 days)
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No
The summary describes a physical dental material (polyvinyl siloxane) used for bite registration and its compatibility with CAD/CAM systems for optical scanning. There is no mention of any software or algorithms that would process data using AI or ML techniques. The "scannable" aspect refers to the material's optical properties, not an intelligent processing capability.
No
The device is a material (polyvinyl siloxane) used for bite registration in dentistry, which is a diagnostic and preparatory step, not a treatment itself. It's used to record the position of teeth for subsequent procedures or to create models.
No
The device is a material (polyvinyl siloxane) used for bite registration in dentistry, not for diagnosing diseases or conditions. Its purpose is to create a physical record of the bite for CAD/CAM systems.
No
The device description clearly states it is a polyvinyl siloxane material, which is a physical substance used for bite registration, not a software program.
Based on the provided information, Flexitime Bite is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. Flexitime Bite is a material used in the mouth to create a physical impression of the bite. It is not used to analyze blood, urine, tissue, or other bodily fluids or substances.
- The intended use is for bite registration and related dental procedures. These are mechanical and physical processes, not diagnostic tests performed on biological samples.
- The device description focuses on its physical properties and compatibility with CAD/CAM systems. This aligns with its function as a dental impression material.
Therefore, Flexitime Bite falls under the category of a dental device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Flexitime bite is intended for the following application:
- Standard bite registrations in the end bite position
- Portrayal of antagonists .
- Coating of bite forks .
- . Key material for needle point registration
- Production of small model segments
Flexitime Bite is an addition-cross-linking polyvinyl siloxane with a very high final Shore D hardness of 40. Its surface properties and optimized color enable it to be optically recorded in CAD/CAM systems to portray the antagonists.
Used for standards bite registrations in the end bite position Coating of bite forks Key material for needle point registration Production of small model segments.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
The product is developed under the project name D 922. Flexitime bite is a scannable polyvinyl siloxane for bite registration with superior hardness and a very short application time in mouth. Its surface properties and optimised colour enable it to be optically recorded in CAD/CAM systems to portray the antagonists. Flexitime Bite can be scanned in the Heraeus scanner and many other CAD/CAM systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility of the new Flexitime Bite prototype was verified in accordance with the international standard. The biocompatibility of Flexitime Bite was documented in a Biological Evaluation Report and the benefitrisk overweighed the possible risks with the new catalyst. (Biological Evaluation Report (Biocompatibility) for Flexitime Bite (Hecker, Troesken, 19. May 2008). In addition toxicological expert opinions are carried out to assess possible risks by using Flexitime Bite as bite registration material and to evaluate recommendations for appropriate warnings. These risk assessments and recommendations have been taken into account in the instruction for use and in the clinical evaluation.
The physical data for the new Flexitime Bite are in accordance with the functional specification for D 922 and the requirements of ISO 13903.
The new Flexitime Bite is a bite registration material which is in general classified as a class I medical device under the Medical Device Directive 93/42/EEC.
- Flexitime Bite represents a well-known type of bite registration material which has . proven to exhibit the expected performance and clinical effectiveness.
- . There is no hint for undesirable effects and potential risks when Flexitime Bite is applied according to the instructions for use.
Considering the evaluated data and technical results for Flexitime Bite it is concluded that the product exhibits the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighed against their benefits in dentistry. Therefore a positive risks versus benefits ratio was stated by the expert for Flexitime Bite (clinical evaluation report according to MEDDEV 2.7.1. for Flexitime Bite, Hecker, 06.06.2008)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
K0825a1
Heraeus Kulzer, Inc. Product Name: Flexitime Bite 510(K) Pre-Market Notification Submission
DEC 0 5 2008
. . . .
510(K) Summary & Clinical Evaluation
Reference the enclosed documents:
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
1
Summary of Safety and Effectiveness of Flexitime Bite (Project No.: D922)
1
Reraeus Kulzer GmbH · Alte Heerstraße · 41538 Dormagen
Heraeus Kulzer GmbH Dentistry Division Alte Heerstraße D-41538 Dormagen
Contact Name: Annegrete Wegner Phone + 49 (0) 2133 51 5494 Fax + 49 (0) 2133 51 5016 annegrete.wegner@heraeus.com www.heraeus-kulzer.com
Your reference: Our reference: Statement Flexitime bite function new Your correspondence of:
9 June 2008
Summary of Safety and Effectiveness of Flexitime Bite (Project No.: D922)
1. Description and Intended Use of the Medical Device:
The product is developed under the project name D 922. Flexitime bite is a scannable polyvinyl siloxane for bite registration with superior hardness and a very short application time in mouth. Its surface properties and optimised colour enable it to be optically recorded in CAD/CAM systems to portray the antagonists. Flexitime Bite can be scanned in the Heraeus scanner and many other CAD/CAM systems.
2. Indication List:
Flexitime bite is intended for the following application:
- ◆ Standard bite registrations in the end bite position
- Portrayal of antagonists .
- Coating of bite forks .
- . Key material for needle point registration
- Production of small model segments 해
Sitz der Gesellsch: Hanau · Registergericht: Amtsgericht Hanau HRB 91228 · USt-IdNr. DE 812 593 096 Geschäftsführer: Dr. Martin Haase, Dr. André Kobelt Vorsitzender des Aufsichtsrates: Jan Rinnert
2
K 682591
Statement Flexitime Bite
Page 2
3. Toxicological Evaluation:
In accordance with the European Medical Device Directive 93/42/EEC and national medical device legislation a medical device is required to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes an evaluation of biocompatibility in accordance with EN ISO 10993-1.
The biocompatibility of the new Flexitime Bite prototype was verified in accordance with the international standard. The biocompatibility of Flexitime Bite was documented in a Biological Evaluation Report and the benefitrisk overweighed the possible risks with the new catalyst. (Biological Evaluation Report (Biocompatibility) for Flexitime Bite (Hecker, Troesken, 19. May 2008). In addition toxicological expert opinions are carried out to assess possible risks by using Flexitime Bite as bite registration material and to evaluate recommendations for appropriate warnings. These risk assessments and recommendations have been taken into account in the instruction for use and in the clinical evaluation.
4. Physical Properties and Compliance with ISO 13903:
The physical data for the new Flexitime Bite are in accordance with the functional specification for D 922 and the requirements of ISO 13903.
5. Clinical Evaluation:
The new Flexitime Bite is a bite registration material which is in general classified as a class I medical device under the Medical Device Directive 93/42/EEC.
- Flexitime Bite represents a well-known type of bite registration material which has . proven to exhibit the expected performance and clinical effectiveness.
- . There is no hint for undesirable effects and potential risks when Flexitime Bite is applied according to the instructions for use.
Considering the evaluated data and technical results for Flexitime Bite it is concluded that the product exhibits the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighed against their benefits in dentistry. Therefore a positive risks versus benefits ratio was stated by the expert for Flexitime Bite (clinical evaluation report according to MEDDEV 2.7.1. for Flexitime Bite, Hecker, 06.06.2008)
3
Statement Flexitime Bite
Heraeus
Page 3
6. Summarized Evaluation:
The physical properties meet the requirements of the functional specification and ISO 13903. The biocompatibility of Flexitime Bite was tested according to the requirements of EN ISO 10993 and additional toxicological expert opinions have been carried out. Based upon these results and the above mentioned clinical evaluation it is concluded that the product can be expected to exhibit the claimed performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighed against their benefit in dentistry.
The risk analysis according to EN ISO 14971 which was carried out for Flexitime Bite showed that the application of Flexitime Bite according to the manufacturer's instructions for use shows an acceptable risk.
Flexitime Bite meets all relevant requirements for scannable polyvinyl siloxane bite registration material in accordance with the European Medical Device Directive 93/42/EEC and national medical device legislation. Based on the actual facts Flexitime Bite is considered to be effective and safe when using it in accordance with the manufacturer's information for use.
Annegrete Wegner
Date:
Signature:
Release:
Date: 13. June 2008 Signature
Dr. Martina Hecker
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 5 2008
Ms. Cheryl V. Zimmerman Director, Quality Assurance & Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re: K082591
Trade/Device Name: Flexitime Bite Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: September 5, 2008 Received: September 8, 2008
Dear Ms. Zimmerman:
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.
5
Page 2 - Ms. Zimmerman
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,
Susan Runny
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
6
K,082sa1
Page_1__of__1_
510(k) Number (if Known):
Device Name: Flexitime Bite
Indications For Use:
Flexitime Bite is an addition-cross-linking polyvinyl siloxane with a very high final Shore D hardness of 40. Its surface properties and optimized color enable it to be optically recorded in CAD/CAM systems to portray the antagonists.
Used for standards bite registrations in the end bite position Coating of bite forks Key material for needle point registration Production of small model segments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ OR Over-The-Counter Use |
|---|---|
| ------------------------------------------ | ------------------------------------------------------------------------------------------- |
| (Division Sign-Off) | (Optional Format 1-2-96) |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K082891 |