(53 days)
K760756, KAI0165
Not Found
No
The device is a dental impression material and its delivery system, with no mention of software, algorithms, or data processing.
No.
The device is an impression material used for creating molds, not for treating a disease or condition.
No
This device is an impression material used for creating physical impressions of teeth and oral structures, which is a manufacturing or impression-taking purpose, not for diagnosing a medical condition.
No
The device is a silicone-based condensation curing impression material, which is a physical substance, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for taking impressions of teeth and oral structures for dental procedures (inlays, crowns, bridges, etc.). This is a physical impression of anatomical structures, not a test performed on biological samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the material properties and delivery system for creating a physical mold.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
The device is a dental impression material, which is a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Xantropren Comfort is a silicone based condensation curing impression material used for all inlay, crown and bridge, edentulous and partial impressions. The Xantropren Comfort Activator is the catalyst. This product is packaged in a cartridge delivery system which will dispense equal amounts of base and activator.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Xantopren Comfort is a is silicone based condensation curing impression material used for all inlay, crown and bridge, edentulous and partial impressions. The advantage of Xantopren Comfort Light and Xantopren Comfort Medium is that the product is available in a cartridge delivery system that ensures that the correct amount of base and catalyst is used each time. With the cartridge delivery system a homogenous mix is obtained each time the material is expressed through the mixing tip. The user cannot manipulate the properties of the product because of the delivery system.
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
An evaluation of the clinical handling characteristics was evaluated for: dispensing of material(s), viscosity for application, working time, setting time, color differentiation, quality of impression, ease of disinfection. The putty material was used in conjunction with the low viscosity and the medium viscosity Xantopren. A minimum of 20 impressions were taken.
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)
Clinical handling characteristics were evaluated for dispensing of material(s), viscosity for application, working time, setting time, color differentiation, quality of impression, and ease of disinfection. A minimum of 20 impressions were taken using the putty material in conjunction with low and medium viscosity Xantopren. Dispensing of the putty material was easily accomplished. Low and medium viscosity Xantopren flowed well and were easily extruded through the mixing tip. Both viscosities flowed well around tooth preparation and into the sulcus. Working time and setting time were adequate and within stated ranges. Color differentiation between low and medium viscosities and the putty received an excellent rating. The quality of the impression was very good. Xantopren Light and Medium bonded well to currently marketed products CutterSil Putty Plus and CutterSil Comfort. The injection tips could be angled. Pouring of the impression was compatible with silicone products. Ease of disinfection was consistent with similar materials, and no distortion was observed after disinfection.
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.
K760756, KAI0165
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
§ 872.3660 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
JUN 1 5 1999
510(K) Summary
June 7, 1999 Date:
Heraeus Kulzer, Inc. Address: 4315 S. Lafayette Blvd. South Bend, IN.
- Cheryl V. Zimmerman Contact: 219-299-6662
- Xantopren Comfort Base Device: Xantopren Activator
Substantially Equivalent to:
CutterSil Light [K760756] KAI0165 CutterSil Mucosa CutterSil Universal Hardener (Paste & Liquid) [K760756]
Device Description:
Xantopren Comfort is a is silicone based condensation curing impression material used for all inlay, crown and bridge, edentulous and partial impressions. The advantage of Xantopren Comfort Light and Xantopren Comfort Medium is that the product is available in a cartridge delivery system that ensures that the correct amount of base and catalyst is used each time. With the cartridge delivery system a homogenous mix is obtained each time the material is expressed through the mixing tip. The user cannot manipulate the properties of the product because of the delivery system.
An evaluation of the clinical handling characteristics was evaluated for:
- dispensing of material(s) ●
- viscosity for application .
- working time .
- setting time
- color differentiation e
- quality of impression .
- ease of disinfection. .
The putty material was used in conjunction with the low viscosity and the medium viscosity Xantopren. A minimum of 20 impressions were taken. Dispensing of the putty material is easily accomplished. One measuring scoop provides adequate material for either a bite or quadrant impression tray. Two measuring scoops are sufficient for a full
1
arch impression tray. After bleeding the cartridge, the low and medium Xantopren visciosities flowed well and were easily extruded through the mixing tip with no difficulty. The low and medium viscosity Xantopren were determined to be quite good for impressions. Both viscoisties flow well around the tooth preparation and into the sulcus. The working time and setting time was determined to be adequate, within the ranges stated in the instructions and similar to comparable impression materials. Color differentiation between the low and medium viscosities and the putty's received an excellent rating. The quality of the impression is very good. And both Xantopren Light and Medium bond well to currently marketed products CutterSil Putty Plus and CutterSil Comfort.
The injection tips on the cartridge delivery system can be angled to suit the needs to the dentist. Pouring of the impression is compatible with silicone products (condensation or addition) that are currently in the market place. Ease of disinfection is consistent with similar materials, and no distortion was observed after disinfection.
| PROPERTIES | Xantopren Comfort Light | CutterSil Light |
|---|---|---|
| Mixing Time (s) | - | 30 |
| Working Time (min) | 2:00 | 2:00 |
| Setting Time (min) | 3:00 | 4:00 |
| Shore A Hardness | 36 | - |
| Max. Deformation Under Pressure (%) | 8.0 | 2-10 |
| Recovery From Deformation (%) | >98 | 97.5 |
| Linear Dimensional Change (%) | 1.0 | -1.0 - 0 |
Product Comparison:
| PROPERTIES | Xantopren Comfort Medium | CutterSil Medium |
|---|---|---|
| Mixing Time | - | 45 |
| Working Time | 2:30 | 2:00 |
| Setting Time | 3:30 | 4:00 |
| Shore A Hardness | 38 | - |
| Max. Deformation Under Pressure | 7.5 | 2-10% |
| Recovery From Deformation | >98 | 97.5 |
| Linear Dimensional Change | 1.0 | -1.0 -0 |
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 1999
Ms. Cheryl V. Zimmerman Quality Operations and Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re: K991425 Xantopen® Comfort Trade Name: Requlatory Class: II Product Code: ELW Dated: April 21, 1999 Received: April 23, 1999
Dear Ms. Zimmerman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may Existing major be subject to such additional controls. requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
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Page 2 - Ms. Zimmerman
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if Known):
Device Name: Xantropren Comfort Base Paste and Activator
Indications For Use:
Xantropren Comfort is a silicone based condensation curing impression material used for all inlay, crown and bridge, edentulous and partial impressions. The Xantropren Comfort Activator is the catalyst. This product is packaged in a cartridge delivery system which will dispense equal amounts of base and activator.
(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 | |
|---|---|---|---|---|
| Susan Runver | (Optional Format 1-2-96) | |||
| (Division Sign-Off) | ||||
| Division of Dental, Infection Control, | ||||
| and General Hospital Devices | ||||
| 510(k) Number | 1911925 |