(169 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a temporary dental restorative material. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is a material for fabricating temporary dental restorations, not a therapeutic device that treats or prevents a disease or condition.
No
Explanation: The device is a material for fabricating temporary dental prostheses, not for diagnosing medical conditions. Its intended use is fabrication, and the performance studies relate to material properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly indicates that Kingscross is a physical material (a composite) used for fabricating temporary dental prostheses. It is a two-component system based on chemical components and is mixed and dispensed physically. There is no mention of software as the primary or sole component of the device.
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 material is used for the "fabrication of temporary prostheses" and "customization of prefabricated acrylic and metal crowns." This is a direct application within the patient's mouth or for creating devices that will be placed in the mouth.
- Device Description: The description details a "two-component system based on a multifunctional acryl composite" used for creating physical restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological samples to gain diagnostic information. This device is a material used for creating dental restorations, which is a therapeutic or restorative purpose, not a diagnostic one.
N/A
Intended Use / Indications for Use
Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
Kingscross, which was developed by Kettenbach, is a highly esthetic composite of fabricating temporary restorations. The two-component system based on a multifunctional acryl composite is produced using no Bisphenol-A or Bisphenol-A precursors in the manufacturing process It has similar properties to a filling material and is available in the following shades: A1. A2, A3, A3.5, B1, B3, Bleach white. Kingscross temporary restorations can also be adjusted and customized using lightcuring composites. The two components (base and catalyst paste) are mixed by using a 50 ml cartridge at the ratio of 10:1 with a dispensing gun. By varying the percentages of two chemical components in the base paste with different percentages of organic peroxide in the catalyst paste four different product variations with different mechanical properties are realized.
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)
Biocompatiblity tests have been performed to assure biological safety in accordance with the ISO 10993 family. Tests in respect to cytotoxicity (ISO 10993-5), mutagenicity (OECD 487), sensitization and mucosa irritation (ISO 10993-10) and a chemical analysis showed, that Kingscross materials' biocompatibility data is comparable to other materials on the market. Additionally bench testing was performed to allow an evaluation of the mechanical properties of Kingscross in comparison to already marketed products. The evaluation covers - E-Modulus (ADA/ANSI Specification No. 53, subclause 7.6) . - Flexible strength (ADA/ANSI Specification No. 53, subclause 7.6) - Impact strength - Compressive strength (ISO 9917-1, Annex D) . - Diametral tensile strength (ADA/ANSI Specification No. 27:1976) . - Volume shrinkage (DIN 13907) . - Max. temperature on cure - Inhibition layer . - . Extrusion force. The results indicate adequate strength results compared to leading temporary crown and bridge materials.
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.
K073296, K853052, K101710, K924830
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
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
DEC 2 7 2012
510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, Kettenbach GmbH & Co KG herewith submits a Summary of Safety and Effectiveness.
Name and address of manufacturer:
Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany Establishment Registration No .: 9681356 Owner/Operator Number: 9022134
Name, title and phone number of official correspondent: Simon, Katia Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail:katja.simon@kettenbach.de
Name, title and phone number of U.S. Agent (Contact):
Roggenbau. Wilfried InterGest North America LLC. 400 Oser Ave., Suite 1650 Hauppauge, NY 11788 Phone: 631 5010500 ext Fax: 631 5011060 E-mail: roggenbauw@intergestna.com
Date of preparation:
November 23, 2012
Device Identification:
Device Trade Name: Versions: Common Name:
Kinascross B; PL-C+B-08; PL-C+B-10, PL-C+B-12 Temporary crown and bridge resin
1
Classification of the device:
Device Classification Name: Product Code: Device Classification No .: Panel: Regulatory Status:
Crown And Bridge, Temporary, Resin EBG Part 872.3770 Dental Class II
Device Description:
Kingscross, which was developed by Kettenbach, is a highly esthetic composite of fabricating temporary restorations. The two-component system based on a multifunctional acryl composite is produced using no Bisphenol-A or Bisphenol-A precursors in the manufacturing process It has similar properties to a filling material and is available in the following shades:
A1. A2, A3, A3.5, B1, B3, Bleach white.
Kingscross temporary restorations can also be adjusted and customized using lightcuring composites.
The two components (base and catalyst paste) are mixed by using a 50 ml cartridge at the ratio of 10:1 with a dispensing gun.
By varying the percentages of two chemical components in the base paste with different percentages of organic peroxide in the catalyst paste four different product variations with different mechanical properties are realized.
Intended Use:
Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.
| Predicate devices: | |
|---|---|
| Device Trade Name: | Integrity |
| Applicant: | Dentsply Intl. |
| 510(k) No.: | K853052 |
| Device Trade Name: | Luxatemp Ultra/Star |
| Applicant: | DMG USA, Inc. |
| 510(k) No.: | K101710 |
| Device Trade Name: | Luxatemp Automix |
| Applicant: | DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH |
| 510(k) No.: | K924830 |
| Device Trade Name: | Protemp Plus |
| Applicant: | 3M Espe |
| 510(k) No.: | K073296 |
2
| | Substantial Equivalent
Devices
Kingscross | | | Predicate Devices | | | | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------|-------------------|----------------------------------------------------------------------------------------------------------|-------------------------|----------------------------|-------------------------|
| | B | PL-
C+B-
12 | PL-
C+B-
10 | PL-
C+B-
08 | Dentsply
Integrity | DMG
Luxatemp
Star | DMG
Luxatemp
Automix | 3M Espe
Protemp Plus |
| Intended
Use | Kingscross temporary crown
and bridge material is intended
to be used for fabrication
temporary prostheses, such as
crowns, partial crowns, bridges,
inlays, onlays and veneers, and
for customization of
prefabricated acrylic and metal
crowns and for fabrication of
long-term temporary
restorations until a permanent
restoration is fabricated. | | | | For the fabrication of temporary crowns and bridges until the
permanent restoration can be delivered. | | | |
| Application
Mixing | 2-paste-system (catalyst/base) | | | | Same | Same | Same | Same |
| | Dispensing gun, cartridge,
mixing tip | | | | Same | Same | Same | Same |
predicate devices. A comparison of the mechanical properties has also been performed in respect to the parameters and standards referenced under "Summary of Non-Clinical Performance Testing".
The results also demonstrate substantial equivalence to the predicate devices.
The Kingscross temporary crown and bridges materials are considered substantially equivalent to the Protemp Plus (K073296), Dentsply Integrity (K853052), Luxatemp Ultra/Star (K101710) and Luxatemp Automix (K924830).
There is no significant difference in intended use or technology. Each version of the Kingscross material is substantially equivalent to the above listed predicate devices.
3
Summary of Non-Clinical Performance Testing:
Biocompatiblity tests have been performed to assure biological safety in accordance with the ISO 10993 family. Tests in respect to cytotoxicity (ISO 10993-5), mutagenicity (OECD 487), sensitization and mucosa irritation (ISO 10993-10) and a chemical analysis showed, that Kingscross materials' biocompatibility data is comparable to other materials on the market.
Additionally bench testing was performed to allow an evaluation of the mechanical properties of Kingscross in comparison to already marketed products. The evaluation covers
- E-Modulus (ADA/ANSI Specification No. 53, subclause 7.6) .
- Flexible strength (ADA/ANSI Specification No. 53, subclause 7.6)
- Impact strength
- Compressive strength (ISO 9917-1, Annex D) .
- Diametral tensile strength (ADA/ANSI Specification No. 27:1976) .
- Volume shrinkage (DIN 13907) .
- Max. temperature on cure
- Inhibition layer .
- . Extrusion force
The results indicate adequate strength results compared to leading temporary crown and bridge materials.
Conclusion:
Kettenbach GmbH & Co KG believes that the Kingscross temporary crown and bridge material is substantially equivalent to the currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards. The figure is positioned to the right of a circular seal that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2012
Mr. Juergen Berger Regulatory Affairs Manager Kettenbach GmbH & Company KG Im Heerfeld 7 Eschenburg, Hessen Germany 35713
Re: K122039
Trade/Device Name: Kingscross Temporary Crown and Bridge Material Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: December 12, 2012 Received: December 26, 2012
Dear Mr. Berger:
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.
5
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 that I Drederal statutes and regulations administered by other Federal agencies. You must or any I 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 Cl it Fart 607); adoling (21 OFF 1 CFR 803); good manufacturing practice requirements as set de rico-related davers overily)S) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by ovisions (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 rr you acsille opeofics and 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 now the regulations 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame Q. Ulmer
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
6
Indications for Use
510(k) number (if known): K122039
Device Name:
Kingscross temporary crown and bridge material
Indications for Use:
mated on 1000.
Kingscross temporary crown and bridge material is intended to be used for fabrication of rangoroo tomperary crowns, partial crowns, bridges, inlays, onlays and veneers, and tor customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.
X Prescription Use (Part 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green -S Sheeria A. Green -3
2012.12.27 11:28:05 -05'00' For Susan Runner, DDS
(Division Sign-Off) (Division Sign-On)
Division of Anesthealology, General Hospital Division of Antol, Dental Devices
K122039 510(k) Number;
Page 1 of 1