(60 days)
Not Found
No
The document describes a silicone impression material used in dentistry, with no mention of AI or ML technology in its intended use, device description, or performance studies.
No.
The device is used to take impressions of the patient's mouth to create plaster casts for diagnosis and treatment planning, not to treat a disease or condition directly.
No
This device is an impression material used to obtain anatomical data of a patient's mouth. While the resulting plaster cast may be used to "diagnose problems", the device itself does not perform the diagnosis. It is a tool for data collection, not diagnosis.
No
The device description clearly states it is an "elastomeric material" and describes its physical properties and packaging (jars and syringes), 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 obtain anatomical data of the patient's mouth for diagnosis, intervention planning, and checking effectiveness. This is a physical impression material used directly on the patient.
- Device Description: The device is described as an elastomeric material used by dentists to create physical impressions of the mouth.
- Lack of In Vitro Diagnostic Characteristics: An IVD is a medical device intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This device does not examine specimens in vitro. It is used in vivo to create a physical mold.
Therefore, while it is a medical device used in the diagnostic process, it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PUTTY SOFT is to be used as preliminary materials for:
-Two-step Putty-wash impression technique
-One-step Putty-wash impression technique
HEAVY BODY materials for:
-One-step impression technique (simultaneous technique) using single or dual viscosities
-Two-step impression technique using dual viscosities
-Functional impression
MEDIUM/MONOPHASE/REGULAR BODY tray or syringeable impression material for:
-Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)
-Functional impressions
-Fabricating crown and bridgework or inlays
-Fabricating full or partial dentures
-Reline impressions
-Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
-Transferring root posts when fabricating posts and cores indirectly
LIGHT BODY is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique
-One-step putty-wash impression technique
-Two-step impression technique using dual viscosities
-Reline impressions
-Fabricating full or partial dentures
EXTRA LIGHT BODY is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique
-One-step putty-wash impression technique
-Two-step impression technique using dual viscosities
-Reline impressions
-Fabricating full or partial dentures
BITE REGISTRATION is used for impression as below.
-Taking occlusal surfaces
-Confirming occlusal surfaces
-Recording after putting the articulator
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
The IMICRYL family of silicone impression materials: includes the brand names SPIRIAS, NICETY, REFLECT and PE Sil. It is used by dentists to obtain anatomical data of the patient's mouth and then to obtain a useful plaster cast to diagnose problems, identify necessary interventions and/or check their effectiveness. They are elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy and resistance to permanent deformation, cured by addition reaction.
The IMICRYL family of silicone impression materials consists of six different viscosities (putty soft, heavy body, medium/monophase/regular body, light body, extra light body, bite registration) for various application systems. Putty Soft consists of 1:1 250 and 1:1 300 mL jars, other consistencies 1:1 50 mL syringes. Although the consistency and composition of medium, monophase and regular body products, which have type 2 consistency, are exactly the same, they are offered for sale under three different names.
IMICRYL impression materials meet the requirements of ISO 4823:2021 Dentistry- Elastomeric impression and bite registration materials standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
Non-clinical performance testing was performed:
Biocompatibility Testing: Cytotoxicity, irritation and sensitization tests of the device were performed. The device is biocompatible.
Physical Testing: In-vitro bench tests were performed on the IMICRYL Impression Materials according to the requirements in ISO 4823:2021 Dentistry-Elastomeric impression and bite registration materials.
Bench tests included in support of the substantial equivalence of IMICRYL Impression Materials are:
- Consistency
- Working Time
- Mixing Time .
- Detail Reproduction
- Compatibility with Gypsum
- . Linear Dimensional Change
- Elastic Recovery
- Strain-in-Compression
- Time in Mouth
- . Compression Set
- Hardness ●
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 11, 2022
IMICRYL Dis Malzemeleri San. Ve Tic. A.S. Husamettin Sonmez General Manager Fetih Mahallesi Mahir Sokak No:5/201 Konya, Karatay 42030 TURKEY
Re: K213890
Trade/Device Name: IMICRYL Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: December 6, 2021 Received: December 13, 2021
Dear Husamettin Sonmez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE., Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213890
Device Name IMICRYL Impression Materials
| Indications for Use (Describe) | |
|---|---|
| PUTTY SOFT is to be used as preliminary materials for: | |
| -Two-step Putty-wash impression technique | |
| -One-step Putty-wash impression technique | |
| HEAVY BODY materials for: | |
| -One-step impression technique (simultaneous technique) using single or dual viscosities | |
| -Two-step impression technique using dual viscosities | |
| -Functional impression | |
| MEDIUM/MONOPHASE/REGULAR BODY tray or syringeable impression material for: | |
| -Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components) | |
| -Functional impressions | |
| -Fabricating crown and bridgework or inlays | |
| -Fabricating full or partial dentures | |
| -Reline impressions | |
| -Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques | |
| -Transferring root posts when fabricating posts and cores indirectly | |
| LIGHT BODY is to be used as syringeable impression materials for: | |
| -Two-step putty-wash impression technique | |
| -One-step putty-wash impression technique | |
| -Two-step impression technique using dual viscosities | |
| -Reline impressions | |
| -Fabricating full or partial dentures | |
| EXTRA LIGHT BODY is to be used as syringeable impression materials for: | |
| -Two-step putty-wash impression technique | |
| -One-step putty-wash impression technique | |
| -Two-step impression technique using dual viscosities | |
| -Reline impressions | |
| -Fabricating full or partial dentures | |
| BITE REGISTRATION is used for impression as below. | |
| -Taking occlusal surfaces | |
| -Confirming occlusal surfaces | |
| -Recording after putting the articulator | |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.# CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Image /page/4/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a blue circle with the letters "IMI" inside of a white shape that resembles a tooth. To the right of the circle is the word "IMICRYL" in blue, and below the circle is the text "DIS MALZEMELERI SAN. VE TIC A.S." in a smaller blue font.
510(k) Summary - K213890
IMICRYL Impression Materials
The IMICRYL family of silicone impression materials: includes the brand names SPIRIAS, NICETY, REFLECT and PE Sil.
Date of Summary Preparation: November 30, 2021
Type of Submission: Traditional 510(k)
SUBMITTER INFORMATION:
Company Name: IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
Company Address: Fetih Mahallesi Mahir Sokak No: 5/201 Zip Code:42030 Karatay/Konya/TURKEY
Phone Number: 0090 444 71 30
Fax Number: 0090 332 355 76 19
Contact Person: Husamettin SONMEZ
Phone: 0090 444 71 30 ext: 120
E-mail: kaliteguvence@imicryl.com
Secondary Contact Person: Muhammed Hulusi SONMEZ
Phone: 0090 542 372 27 23
E-mail: hsonmez@imicryl.com.tr
DEVICE INFORMATION:
Trade Name: IMICRYL Impression Materials Common Name: Impression Material Product Code: ELW Classification: Class II Classification Name: Material, Impression Regulation Number: 21 CFR 872.3660
Review Panel: Dental
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Image /page/5/Picture/0 description: The image shows the logo for IMICRYL. The logo consists of a circular emblem with the letters "IMI" inside, followed by the word "IMICRYL" in bold, blue letters. Below the logo is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in a smaller font size, also in blue.
PREDICATE DEVICES:
IMICRYL Impression Materials is substantially equivalent to the following marketed product:
| COMPANY | DEVICE | 510(k) NUMBER | PRODUCT CODE |
|---|---|---|---|
| Osstem Implant Co., | |||
| Ltd. | HySil Impression Materials | K170736 | ELW |
INDICATION FOR USE:
SPIRIAS, NICETY, REFLECT and PE Sil Putty Soft is to be used as preliminary materials for: Two-step Putty-wash impression technique One-step Putty-wash impression technique
SPIRIAS, NICETY, REFLECT and PE Sil Heavy Bodied materials for: One-step impression technique (simultaneous technique) using single or dual viscosities Two-step impression technique using dual viscosities Functional impression
SPIRIAS, NICETY, REFLECT and PE Sil Medium/Monophase/Reqular Bodies tray or syringeable impression material for:
- · Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)
- · Functional impressions
- · Fabricating crown and bridgework or inlays
- Fabricating full or partial dentures
- · Reline impressions
- Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
- · Transferring root posts when fabricating posts and cores indirectly
SPIRIAS, NICETY, REFLECT and PE Sil Light Body is to be used as syringeable impression materials for: Two-step putty-wash impression technique
One-step putty-wash impression technique
Two-step impression technique using dual viscosities
Reline impressions
Fabricating full or partial dentures
SPIRIAS, NICETY, REFLECT and PE Sil Extra Light Body is to be used as syringeable impression
materials for: Two-step putty-wash impression technique One-step putty-wash impression technique Two-step impression technique using dual viscosities Reline impressions Fabricating full or partial dentures
SPIRIAS, NICETY, REFLECT and PE Sil Bite Registration is used for impression as below.
- Taking occlusal surfaces
- Confirming occlusal surfaces
- Recording after putting the articulator
6
Image /page/6/Picture/0 description: The image contains a logo for IMICRYL. The logo consists of a circular emblem on the left, containing the letters "IMI" inside a tooth-shaped figure. To the right of the emblem is the word "IMICRYL" in bold, blue letters, with a registered trademark symbol. Below the logo is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş."
DEVICE DESCRIPTION:
The IMICRYL family of silicone impression materials: includes the brand names SPIRIAS, NICETY, REFLECT and PE Sil. It is used by dentists to obtain anatomical data of the patient's mouth and then to obtain a useful plaster cast to diagnose problems, identify necessary interventions and/or check their effectiveness. They are elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy and resistance to permanent deformation, cured by addition reaction.
The IMICRYL family of silicone impression materials consists of six different viscosities (putty soft, heavy body, medium/monophase/regular body, light body, extra light body, bite registration) for various application systems. Putty Soft consists of 1:1 250 and 1:1 300 mL jars, other consistencies 1:1 50 mL syringes. Although the consistency and composition of medium, monophase and regular body products, which have type 2 consistency, are exactly the same, they are offered for sale under three different names.
IMICRYL impression materials meet the requirements of ISO 4823:2021 Dentistry- Elastomeric impression and bite registration materials standard.
SUBSTANTIAL EQUIVALENCE:
The applicant device has the same intended use as the 510(k) cleared predicates listed above. Table 1 below shows a comparison of IMICRYL Impression Materials and the predicates.
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Image /page/7/Picture/0 description: The image contains the logo for IMICRYL. The logo consists of the letters "IMI" inside of an oval shape on the left, followed by the word "IMICRYL" in large, bold, blue letters. Below the logo is the text "DİŞ MALZEMELERİ SAN. VE TİC A.Ş." in smaller, black letters.
Table 1: Comparison with Predicate Device
| DESCRIPTIVE | NEW DEVICE | PREDICATE DEVICE | REMARK |
|---|---|---|---|
| INFORMATION | IMICRYL Impression Materials (K213890) | HySil Impression Materials (K170736) | |
| INDICATIONS FOR USE | |||
| Putty Soft | |||
| SPIRIAS, NICETY, REFLECT and PE Sil Putty Soft is to be used as | |||
| preliminary materials for: | |||
| Two-step Putty-wash impression technique | |||
| One-step Putty-wash impression technique | Putty | ||
| HySil Putty is to be used as preliminary materials for: | |||
| Two-step Putty-wash impression technique | |||
| One-step Putty-wash impression technique | Same Indications for Use | ||
| Heavy Body | |||
| SPIRIAS, NICETY, REFLECT and PE Sil Heavy Bodied materials | |||
| for: | |||
| One-step impression technique (simultaneous technique) | |||
| using single or dual viscosities | |||
| Two-step impression technique using dual viscosities | |||
| Functional impressions | Heavy Body | ||
| HySil Heavy is to be used as heavy-bodied materials for: | |||
| One-step impression technique (simultaneous technique) | |||
| using single or dual viscosities | |||
| Two-step impression technique using dual viscosities | |||
| Functional impressions | |||
| Medium/Monophase/Regular Body | |||
| SPIRIAS, NICETY, REFLECT and PE Sil | |||
| Medium/Monophase/Regular Bodies tray or syringeable | |||
| impression material for: | |||
| _ Taking impressions over fixed/removable restorations and | |||
| implants (i.e., transferring impression posts and bridge | |||
| components) | |||
| _ Functional impressions | |||
| _ Fabricating crown and bridgework or inlays | |||
| _ Fabricating full or partial dentures | |||
| _ Reline impressions | |||
| _ Use in the simultaneous mixing technique as well as the | |||
| putty-wash and triple tray techniques | |||
| _ Transferring root posts when fabricating posts and cores | |||
| indirectly | Medium Body | ||
| HySil Mono is to be used as a medium-bodied tray or | |||
| syringeable impression material for: | |||
| _ Taking impressions over fixed/removable restorations | |||
| and implants (i.e., transferring impression posts and bridge | |||
| components) | |||
| _ Functional impressions | |||
| _ Fabricating crown and bridgework or inlays | |||
| _ Fabricating full or partial dentures | |||
| _ Reline impressions | |||
| _ Use in the simultaneous mixing technique as well as the | |||
| putty-wash and triple tray techniques | |||
| _ Transferring root posts when fabricating posts and cores | |||
| indirectly | |||
| Light Body | |||
| SPIRIAS, NICETY, REFLECT and PE Sil Light Body is to be used as | |||
| syringeable impression materials for: | |||
| Two-step putty-wash impression technique | Light Body | ||
| HySil Light is to be used as syringeable impression | |||
| materials for: | |||
| Two-step putty-wash impression technique |
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Image /page/8/Picture/0 description: The image contains the logo for IMICRYL diş malzemeleri san. ve tic a.ş. The logo features the text "IMICRYL" in a bold, sans-serif font, with the trademark symbol to the right of the word. To the left of the text is a circular graphic with the letters "IMI" inside. Below the text is the phrase "diş malzemeleri san. ve tic a.ş." in a smaller font.
| | One-step putty-wash impression technique
Two-step impression technique using dual viscosities
Reline impressions
• Fabricating full or partial dentures | | One-step putty-wash impression technique
Two-step impression technique using dual viscosities
Reline impressions
• Fabricating full or partial dentures | | | | | | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------|---------------------|---------------|---------------------|---------------|---------------------|
| | Extra Light Body
SPIRIAS, NICETY, REFLECT and PE Sil Extra Light Body is to be
used as syringeable impression materials for:
Two-step putty-wash impression technique
One-step putty-wash impression technique
Two-step impression technique using dual viscosities
Reline impressions
Fabricating full or partial dentures | | Extra Light Body
HySil Extra Light is to be used as syringeable impression
materials for:
Two-step putty-wash impression technique
One-step putty-wash impression technique
Two-step impression technique using dual viscosities
Reline impressions
Fabricating full or partial dentures | | | | | | | |
| | Bite Registration
SPIRIAS, NICETY, REFLECT and PE Sil Bite Registration is used
for impression as below.
Taking occlusal surfaces
Confirming occlusal surfaces
Recording after putting the articulator | | Bite
HySil Bite is used for impression as below.
Taking occlusal surfaces
Confirming occlusal surfaces
Recording after putting the articulator | | | | | | | |
| COMPOSITION | Putty Soft, Heavy Body, Medium/Monophase/Regular Body,
Light Body, Extra Light Body, Bite Registration
Vinylpolysiloxane | | Putty, Heavy, Mono, Light,
Extra-Light, Bite
Vinylpolysiloxane | | Composed with same affiliated
material, but ratios of each
component in use are slightly
different. | | | | | |
| PHYSICAL PROPERTIES | Putty Soft | Heavy Body | Medium /
Monophase / Regular
Body | Light Body | Extra Light | | | | | |
| | New
Device | Predicate
Device | New
Device | Predicate
Device | New
Device | Predicate
Device | New
Device | Predicate
Device | New
Device | Predicate
Device |
| Type | Type 0 | Type 0 | Type 1 | Type 1 | Type 2 | Type 2 | Type 3 | Type 3 | Type 3 | Type 3 |
| Consistency | 28,40 mm | 31,27 mm | 30,18 mm | 28,47 mm | 34,35 mm | 35,65 mm | 36,67 mm | 45,60 mm | 43,42 mm | 44,61 mm |
| Working Time | 90 sec | - | 90 sec | 2,022 min | 90 sec | 2,612 min | 90 sec | 2,850 min | 90 sec | 3,6 min |
| Mixing Time | 30 sec | 38 sec | Auto
(30 sec) | Pass | Auto
(30 sec) | Pass | Auto (30 sec) | Pass | Auto (30 sec) | Pass |
| Detail Reproduction | 50μm | Pass | 20μm | Pass | 20μm | Pass | 20μm | Pass | 20μm | Pass |
| Compatibility with
gypsum | 50μm | Pass | 20μm | Pass | 20μm | Pass | 20μm | Pass | 20μm | Pass |
| Linear Dimensional
change | 0,01% | 0,031 % | 0,01% | 0,02 % | 0,02% | 0,02 % | 0,02% | 0,03 % | 0,02% | 0,027 % |
| Elastic Recovery | 99,00% | 99,8 % | 99,60% | 98,80 % | 99,99% | 98,60 % | 99,99% | 98,70 % | 99,99% | 99,5 % |
| Strain-in-Compression | 1,6% | 1,6 % | 2,30% | 2,30 % | 3,68% | 3,00 % | 3,38 % | 2,30 % | 3,18% | 2,6 % |
| PHYSICAL PROPERTIES | | | | | | | | | | |
| | | | Bite Registration | | | | | | | |
| New Device | | | Predicate Device | | | | | | | |
| Type | | Type B | Type B | | | | | | | |
| Mixing Time | | 30 sec | Pass | | | | | | | |
| Working Time | | 90 sec | Pass | | | | | | | |
| Time in Mouth (minimum) | | 3 min | 1 min. 30 sec. | | | | | | | |
| Linear Dimensional change | 0,02% | | -0,16% | | | | | | | |
| Compression set | | 0.06mm | Pass | | | | | | | |
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Image /page/9/Picture/0 description: The image is a logo for IMICRYL. The logo consists of the word "IMICRYL" in large, bold, blue letters, with a registered trademark symbol next to it. To the left of the word is a blue circle containing the letters "IMI" in white. Below the word "IMICRYL" is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in smaller, blue letters.
50 HD
55 HD
Similarities
Hardness
• IMICRYL Impression Materials; it is exactly similar to the in terms of composition, indications for use, function and physical properties.
• We believe that the prior use of these components in legally marketed devices and the performance data and results support the safety and effectiveness of IMICRYL Impression Materials for the intended use.
10
Image /page/10/Picture/0 description: The image is a logo for IMICRYL. The logo consists of a blue circle with a white tooth-like shape inside, with the letters "IMI" in blue inside the tooth. To the right of the circle is the word "IMICRYL" in blue, with a registered trademark symbol in the upper right corner. Below the logo is the text "DIŞ MALZEMELERI SAN. VE TIC A.Ş." in blue.
NON-CLINICAL PERFORMANCE TESTING:
Biocompatibility Testing:
Cytotoxicity, irritation and sensitization tests of the device were performed. The device is biocompatible.
Physical Testing:
In-vitro bench tests were performed on the IMICRYL Impression Materials according to the requirements in ISO 4823:2021 Dentistry-Elastomeric impression and bite registration materials.
Bench tests included in support of the substantial equivalence of IMICRYL Impression Materials are:
- Consistency
- Working Time
- Mixing Time .
- Detail Reproduction
- Compatibility with Gypsum
- . Linear Dimensional Change
- Elastic Recovery
- Strain-in-Compression
- Time in Mouth
- . Compression Set
- Hardness ●
CONCLUSION
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 872.3660, and based on the information provided in this pre-market notification, IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. concludes that the IMICRYL Impression Materials is safe, effective and substantially equivalent to the predicate devices as described herein. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or risks.