(112 days)
Not Found
No
The device description and intended use describe a traditional dental impression material and its various forms and applications. There is no mention of software, algorithms, data processing, or any other components typically associated with AI/ML. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No
The device is used for taking impressions of anatomical sites (teeth and gums) for the purpose of fabricating dental restorations or dentures, which is a diagnostic or preparatory step rather than a direct therapeutic intervention.
No
Explanation: The device is an impression material used for fabricating dental restorations and dentures, not for diagnosing medical conditions. It aids in the creation of physical models, which is a manufacturing step, not a diagnostic one.
No
The device description clearly states that Suflex Impression Materials are physical, elastomeric materials available in different viscosities and delivery systems (cartridges, foil bags, jars), indicating it is a hardware/material-based device, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the material being used to create impressions of a patient's teeth and gums for the purpose of fabricating dental restorations and prosthetics. This is a direct interaction with the patient's anatomy to create a physical mold.
- Device Description: The device is an impression material, which is a substance used to capture the shape of anatomical structures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The purpose is to create a physical impression, not to analyze biological samples.
The device falls under the category of dental impression materials, which are typically regulated as medical devices, but not as IVDs.
N/A
Intended Use / Indications for Use
- be placed on an impression tray(or infected directly into the mouth, depending on the technique and device)and used to reproduce the structure of a patient's teeth and gums.
- provide models for study and for production of restorative prosthetic devices.
Suflex Putty is to be used as panasil putty material for;
- Two step putty impression technique
- One step putty impression technique
- Two step putty impression technique using a foil(plastic putty spacer) .
- One step putty impression technique for forming functional peripheries. -
Suflex Heavy is to be used a s panasil tray material for;
- One step impression technique using sinte or dual viscosities.
- Two step impression technique using dual viscosities
- Functional impressions. -
Suflex Mono is to be used as panasil monophase material for;
- Taking impression over fixed/removable restorations and implants -(transferring impression posts and bridge components)
- -Fuctional impresssions.
- Fabricating crown and bridgework or inlays. .
- Fabricating full or partical dentures. .
- Reline impressions.
- Use in the simultaneous mixing technique as well as the putty -
- Trnasferring root posts when fabricating posts and cores indirectly. .
Suflex Light is to be used as panaasil contact material for;
- Two step putty impressiontechnique.
- One step putty impression technique.
- One step impression technique using a foil(plastic putty spacer) l
- One step impression technique(simultaneous technique)using dual viscosities. .
- -Reline impressions.
- Fabricating full or partial dentures. -
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Suflex Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Suflex Impression Material family consists of four different viscosities(putty, heavy, mono, light), available in an assortment of delivery systems: traditional 1:1 50ml, automix cartridge, 5:1 362ml foil bags for use in most automatic dispensing and mixing systems, and traditional 1:1 putty jars.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth and gums
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)
Biocompatibility tests have been performed to assure biological safety in accordance with the ISO 10993 family. Tests in respect to cytotoxicity(ISO 10993-5), sensitization and mucosa irritation(ISO 10993-10) and a chemical analysis showed, that Suflex 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 Sulex in comparison to already marketed products. The evaluation covers
Component colours (ISO 4823, 6.1)
Working time (ISO 4823, 6.3)
Compatibility with gypsum (ISO 4823, 6.4)
Consistency(ISO 4823, 6.4)
Detail reproduction(ISO 4823, 6.4)
Linear dimensional change(ISO 4823, 6.4)
Elastic recovery(ISO 4823, 6.4)
Strain-in-compression(ISO 4823, 6.4)
The results indicate adequate consistency results compared to leading Impression materials.
No clinical studies are submitted.
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.
K082560, K954282, K021413, K021410, K050604
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
MAR - 7 2014
Image /page/0/Picture/2 description: The image shows the word "OSSTEM" in bold, black letters. Below the word "OSSTEM" is the word "IMPLANT" in smaller, thinner, black letters. There is a degree symbol to the right of the word "OSSTEM". The background is white.
Osstem Germany GmbH
#Mergenthaler Allee 25, 65760 Eschborn, Germany Tel. +49(0)6196 777 550 · Fax. +49 (0}6196 777 55 06 www.osstem.de, www.sinuskit.com
Osstem Germany GmbH.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Jessica Jung
+49 6196 777 550
HIOSSEN Inc.
Patrick Lim
ELW
888 678 0001
Date: July 12, 2013
- Company and Correspondent making the submission:
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Submitter's Name :
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Address
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Contact :
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Phone:
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Correspondent's Name:
-
Address:
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Contact:
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Phone:
- Device :
Trade or (Proprietary) Name :
Common or usual name :
Classification Name :
Suflex Impression Materials to include: Suflex putty Suflex Heavy Suflex Mono Suflex Light Impression material Material, Impression(21 CFR 872.3660.Product) 21CFR872.3640 Class II
85 Ben Fairless Dr. Fairless Hills, PA 19030
#Mergenthaler Allee 25, 65760 Eschborn, Germany
- Predicate Device: Trade Name: Trade Name: Trade Name:
Trade Name:
Trade Name:
Panasil Impression Materials(K082560) Panasil Impression Materials(K954282) Aquasil Ultra Rigid Smart Wetting Impression Material (K021413) Aquasil Ultra XLV Smart Wetting Impression Material (K021410) Kerr VPS Impression Material(K050604)
1
Image /page/1/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in black and is a stylized font. The word "OSSTEM" is on the top line and the word "IMPLANT" is on the bottom line.
Osstem Germany GmbH.
#Mergenthaler Allec 25, 65760 Eschborn, Germany Tel. +49(0)6196 777 550 · Fax. +49 (0)6196 777 55 06 www.osstem.de. www.sinuskit.com
4. Description:
Suflex Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Suflex Impression Material family consists of four different viscosities(putty, heavy, mono, light), available in an assortment of delivery systems: traditional 1:1 50ml, automix cartridge, 5:1 362ml foil bags for use in most automatic dispensing and mixing systems, and traditional 1:1 putty jars.
5. Intended use
- be placed on an impression tray(or infected directly into the mouth, depending on the technique and device)and used to reproduce the structure of a patient's teeth and gums.
- provide models for study and for production of restorative prosthetic devices.
6. Indication for use
Suflex Putty is to be used as panasil putty material for;
- Two step putty impression technique l
- One step putty impression technique
- Two step putty impression technique using a foil(plastic putty spacer) .
- One step putty impression technique for forming functional peripheries. -
Suflex Heavy is to be used a s panasil tray material for;
- One step impressiontechnique using sinte or dual viscosities. ।
- Two step impression technique using dual viscosities ।
- Functional impressions. -
Suflex Mono is to be used as panasil monophase material for;
- Taking impression over fixed/removable restorations and implants -(transferring impression posts and bridge components)
- -Fuctional impresssions.
- Fabricating crown and bridgework or inlays. .
- Fabricating full or partical dentures. .
- Reline impressions. י
- Use in the simultaneous mixing technique as well as the putty -
- Trnasferring root posts when fabricating posts and cores indirectly. .
Suflex Light is to be used as panaasil contact material for;
- Two step putty impressiontechnique. ।
- One step putty impression technique. ।
- One step impression technique using a foil(plastic putty spacer) l
- One step impression technique(simultaneous technique)using dual viscosities. .
- -Reline impressions.
- Fabricating full or partial dentures. -
2
Image /page/2/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is written in a bold, sans-serif font, with the word "IMPLANT" written in a smaller font below it. There is a degree symbol to the right of the word "OSSTEM".
Osstem Germany GmbH.
#Mergenthaler Allee 25, 65760 Eschborn, Germany Tel. +49(0)6196 777 550 - Fax. +49 (0)6196 777 55 06 www.osstem.de, www.sinuskit.com
7. Summary of Non-Clinical Performance Testing
Biocompatibility tests have been performed to assure biological safety in accordance with the ISO 10993 family. Tests in respect to cytotoxicity(ISO 10993-5), sensitization and mucosa irritation(ISO 10993-10) and a chemical analysis showed, that Suflex 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 Sulex in comparison to already marketed products. The evaluation covers
Component colours (ISO 4823, 6.1)
- Working time (ISO 4823, 6.3)
- | Compatibility with gypsum (ISO 4823, 6.4)
- Consistency(ISO 4823, 6.4)
- Detail reproduction(ISO 4823, 6.4)
- Linear dimensional change(ISO 4823, 6.4)
- Elastic recovery(ISO 4823, 6.4)
- Strain-in-compression(ISO 4823, 6.4)
The results indicate adequate consistency results compared to leading Impression materials.
8. Summarv of clinical testing
No clinical studies are submitted
9. Conclusions
Osstem Germany GmbH believes that the Suflex Impression 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2014
Osstem Germany GmbH C/O Mr. Patrick Lim QA/RA Manager HIOSSEN, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030
Re: K133527
Trade/Device Name: Suflex Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 27, 2013 Received: December 11, 2013
Dear Mr. Lim:
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicaiDevices/ResourcesforYou/Industry/default.htm. 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,
Image /page/4/Picture/7 description: The image shows the name "Erin F. Keith-S" in a stylized font. The name is written in black ink and is easily readable. The letters are bold and have a slightly rounded appearance. The overall impression is that of a professional and well-designed logo or nameplate.
Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image contains the logo for OSSTEM IMPLANT. The word "OSSTEM" is in a bold, sans-serif font, with the letters slightly overlapping each other. The word "IMPLANT" is in a smaller, sans-serif font and is located directly below "OSSTEM". There is a degree symbol to the right of the word "OSSTEM".
Osstem Germany GmbH.
#Mergenthaler Allec 25, 65760 Eschborn, Germany Tel. +49(0)6196 777 550 - Fax. +49 (0)6196 777 55 06 www.osstem.de. www.sinuskit.com
510(k) Number K _133527
Device Name : Suflex impression materials
Indication for use :
Suflex Putty is to be used as panasil putty material for;
- Two step putty impression technique 。
- One step putty impression technique -
- Two step putty impression technique using a foil(plastic putty spacer) l
- One step putty impression technique for forming functional peripheries. .
Suflex Heavy is to be used a s panasil tray material for;
- One step impression technique using single or dual viscosities. ,
- Two step impression technique using dual viscosities .
- Functional impressions. -
Suflex Mono is to be used as panasil monophase material for;
- Taking impression over fixed/removable restorations and implants . (transferring impression posts and bridge components)
- Functional impressions. .
- -Fabricating crown and bridgework or inlays.
- Fabricating full or partial dentures. 1
- Reline impressions. ।
- Use in the simultaneous mixing technique as well as the putty .
- Transferring root posts when fabricating posts and cores indirectly. -
Suflex Light is to be used as panasil contact material for;
- Two step putty impression technique. .
- One step putty impression technique. -
- One step impression technique using a foil(plastic putty spacer) -
- One step impression technique (simultaneous technique) using dual viscosities. -
- Reline impressions. -
- Fabricating full or partial dentures. .
Prescription Use X (Per 21CFR801 Subpart D)
Over-The-Counter Use OR (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner -5
FDA 2024.09.06
07:56:58-05'00'
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