(67 days)
No
The description focuses on the material properties and dispensing system of a dental impression material, with no mention of AI or ML.
No
The device is described as a dental impression material used to create a negative copy of a patient's dental situation, not to treat a condition.
No
Explanation: The device is an impression material used to create a negative copy of a patient's dental situation, not to diagnose a condition.
No
The device description clearly states it is an "addition-curing polyvinyl-siloxane impression material" delivered in cartridges, indicating it is a physical material, 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 to create a "negative copy of the patients' dental situation" for various dental applications (temporaries, crowns, dentures, etc.). This is a physical impression of the patient's anatomy.
- Device Description: It's an "elastomer dental impression material" and an "addition-curing polyvinyl-siloxane impression material." These are materials used to physically capture the shape of teeth and gums.
- Lack of Diagnostic Purpose: The description does not mention any diagnostic purpose. It's used to create a model for fabricating dental prosthetics or appliances, not to analyze biological samples or provide diagnostic information about a patient's health.
- No Mention of Biological Samples: IVDs are typically used to test biological samples (blood, urine, tissue, etc.). This device interacts directly with the patient's mouth to create a physical mold.
Therefore, Xantasil is a dental impression material used for creating physical models, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Xantasil is a medium flow, addition-curing, elastomer dental impression material that can be used to cover all impression needs where a traditional alginate material would be used, such as impressions for temporaries, crown and bridges, removable dentures, orthodontic models, opposing jaw models, splints, mouth guards and bleaching trays. It is used to get a negative copy of the patients' dental situation.
Product codes
ELW
Device Description
Xantasil is an addition-curing polyvinyl-siloxane impression material. Xantasil is delivered in 50 ml and 380 ml cartridges. Xantasil is an optimized A-silicone impression material with medium consistency meant as a replacement for alginates. The mouth removal time for the product is 1.5 minutes Xantasil is for use in the Dynamix automatic dispensing and mixing system and the 1:1 Cartridge dispenser.
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)
The physical properties of Xantasil like Flexitime Monophase (K000629) and Flexitime Monophase ProScan (K113574) are in compliance with ISO 4823.
The biological compatibility of Xantasil was verified utilizing bridging data from predicates in accordance with the international standard ISO 10993-1. The biocompatibility of Xantasil in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit/risk relation has been judged as positive. The clinical evaluation is intended to critically evaluate the clinical benefits of the medical device in comparison to its potential risks. Therefore, any clinical evaluation is part of the compulsory risk management process according to EN ISO 14971, and critical findings must further be considered in the current risk management process of the medical device manufacturer responsible for the evaluated device. On this background, the clinical evaluation was performed. This critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan. Considering the evaluated scientific data and technical results for Xantasil it is concluded that the products can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and accepted, when weighed against their benefit to dentistry. Therefore, a positive benefit versus risk ratio can be stated by the experts for Xantasil, provided that the products applied in accordance with its intended use as outlined in the manufacturer's instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Working Time: ≥2:30 min
- Detail Reproduction: ≤20 µm
- Linear Dimensional Change: ≤1,5%
- Compatibility to Gypsum: ≤20 µm
- Strain in Compression: ≤20%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K130647
Heraeus
510(k) Summary according to 21 CFR 807.92(c)
MAY 1 7 2013
; '
ﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ .
| Submitter Information: | |
|---|---|
| Name | Heraeus Kulzer, LLC |
| Address | 300 Heraeus Way |
| South Bend, IN 46614 | |
| Phone Number | (574) 299-5421 |
| Fax Number | (574) 291-0080 |
| Establishment Registration Number | 1925223 |
| Name of Contact Person | Jamie Meama |
| Date Prepared | December 31, 2012 |
| Name of Device: | |
| Trade or Proprietary Name | Xantasil |
| Common or Usual Name | Impression Material |
| Classification Name | Dental ELW |
| Device Classification | Class II |
| Classification Panel: | 76 Dental |
| Regulation: | 21 CFR 872.3660 |
| Product code (s): | ELW |
| Legally marketed devices(s) to which | |
| equivalence is claimed: | Flexitime K000629 |
| Flexitime Monophase Pro Scan K113574 | |
| Reason for 510(k) Submission: | This submission is to notify FDA of an optimized |
| A-silicone impression material with medium | |
| consistency meant as a replacement for alginates. | |
| Device Description: | |
| Xantasil is an addition-curing polyvinyl-siloxane | |
| impression material. Xantasil is delivered in 50 ml | |
| and 380 ml cartridges. | |
| Xantasil is an optimized A-silicone impression | |
| material with medium consistency meant as a | |
| replacement for alginates. | |
| The mouth removal time for the product is 1.5 | |
| minutes | |
| Xantasil is for use in the Dynamix automatic | |
| dispensing and mixing system and the 1:1 Cartridge | |
| dispenser. | |
| Indications for use: | |
| Xantasil is a medium flow, addition-curing, | |
| elastomer dental impression material that can be | |
| used to cover all impression needs where a | |
| traditional alginate material would be used, such as | |
| impressions for temporaries, crown and bridges, | |
| removable dentures, orthodontic models, opposing | |
| jaw models, splints, mouth guards and bleaching | |
| trays. It is used to get a negative copy of the | |
| patients' dental situation. |
1
Image /page/1/Picture/0 description: The image shows the word "Heraeus" in a bold, outlined font. The letters are slightly distressed, giving the word a textured appearance. The word is presented in a horizontal orientation, filling the majority of the frame.
Summary of the Technological Characteristics of the New Devices Compared to the Predicate Devices Flexitime Monophase K000629 & Flexitime Monophase K113574:
The physical properties of Xantasil like Flexitime Monophase (K000629) and Flexitime Monophase ProScan (K113574) are in compliance with ISO 4823.
Similarities as Compared to Predicates:
| Attribute | Xantasil | Monophase K000629 | Monophase Pro Scan K113574 |
|---|---|---|---|
| FDA Code | ELW | ELW | ELW |
| Mixing Time, | |||
| hand | |||
| spatulated | n.a. | n.a. | n.a. |
| Working Time | ≥2:30 min | ≥2:30 min | ≥2:30 min |
| Detail | |||
| Reproduction | ≤20 µm | ≤20 µm | ≤20 µm |
| Linear | |||
| Dimensional | |||
| Change | ≤1,5% | ≤1,5% | ≤1,5% |
| Compatibility | |||
| to Gypsum | ≤20 µm | ≤20 µm | ≤20 µm |
| Strain in | |||
| Compression | ≤20% | ≤20% | ≤20% |
Differences as Compared to Predicate:
No difference in technological characteristics.
Results Summary:
Xantasil is substantially equivalent to Flexitime Monophase ProScan and Flexitime Monophase. All of the products are indicated for taking impression materials of suited techniques.
2
Image /page/2/Picture/0 description: The image shows the word "Heraeus" in a stylized font. The letters are outlined with a thick border, giving them a bold appearance. The font is sans-serif and appears to be a custom design.
Conclusions Drawn From Non-Clinical and Clinical Data:
The biological compatibility of Xantasil was verified utilizing bridging data from predicates in accordance with the international standard ISO 10993-1.
The biocompatibility of Xantasil in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit/risk relation has been judged as positive.
The clinical evaluation is intended to critically evaluate the clinical benefits of the medical device in comparison to its potential risks. Therefore, any clinical evaluation is part of the compulsory risk management process according to EN ISO 14971, and critical findings must further be considered in the current risk management process of the medical device manufacturer responsible for the evaluated device.
On this background, the clinical evaluation was performed. This critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.
Considering the evaluated scientific data and technical results for Xantasil it is concluded that the products can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and accepted, when weighed against their benefit to dentistry. Therefore, a positive benefit versus risk ratio can be stated by the experts for Xantasil, provided that the products applied in accordance with its intended use as outlined in the manufacturer's instructions for use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2013
Ms. Jamie Mearna Associate Quality Assurance/Regulatory Affairs Manager Heraeus Kulzer, Limited Liability Company · 300 Heraeus Way SOUTH BEND IN 46614
Re: K130647
Trade/Device Name: Xantasil Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 7, 2013 Received: March 20, 2013
Dear Ms. Mearna:
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.
4
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 devicerelated 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/ReportalProblem/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,
Digitally signed by Mary S. Runner
DN: C=US, O=U.S. Government,
OU=HHS, OU=FDA, ou=People,
Susan Runner, DDS, MA O=Mary S. Runner -S.
00
0.9.2342.19200300.100.1.1=13000
950/
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
Indications for Use 1306
510(k) Number (if known):
Device Name: Xantasil
Indications for Use:
Xantasil is a medium flow, addition-curing, elastomer dental impression material that can be used to cover all impression needs where a traditional alginate material would be used, such as impressions for temporaries, crown and bridges, removable dentures, orthodontic models, opposing jaw models, splints, mouth guards and bleaching trays. It is used to get a negative copy of the patients' dental situation.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) S. Runner -S 013:04.24 07:37:07
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K130647