(4 days)
The Lascod family of silicone impression materials includes the brand names: Ghenesyl, Kromopan Sil are used by dentists to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define required interventions, and/or check their effectiveness.
The Ghenesyl Putty and Kromopan Sil Putty products are indicated for obtaining preliminary impressions for the two-step putty/wash and base for the sandwich technique. The impression can be electroplated.
The Ghenesyl Body and Kromopan Sil Body products are indicated for the two-step putty/wash and for the sandwich technique. The impression can be electroplated.
The Ghenesyl Mono and Kromopan Sil mono products are indicated for monophasic technique, though it can be used also with Super Light Body / Light Body / Regular Body wash silicones as support material inside individual impression tray or standard stainless-steel impression tray.
Kromopan Sil Bite and Oklurest used by dentists to take impressions of occlusal surfaces in order to confirm the occlusal surfaces onto the plaster models assembled on an articulator.
Kromopan Sil Bite and Oklurest and products are indicated for orthodontic occlusion registration keys for gnathological registrations, inter-maxillary registration keys for centered positions, eruptions and ectopic eruptions, registration for cephalometric analysis which also require subsequent scanning with CAD systems.
Lascod Impression Materials are addition-curing polyvinylsiloxane silicones. They exhibit excellent accuracy, maximum thixotropy, and hydrophilicity. Additional elastomeric properties include, fast in the mouth setting time, high resistance to tear, dimensional accuracy, and resistance to permanent deformation. The Lascod impression material product line boasts multiple different variants: hard and soft putty; heavy, regular, light and superlight body – all putties and bodies, are available both as normal and fast set; mono and bite. Putties are provided in 300 or 150 ml plastic jars. The body and the bite product lines, are usually offered in the standard (1: 1) 50 ml dual barrel cartridges. The Mono product line is provided in two forms; a standard (1: 1) 50 ml dual cartridge, and a (5: 1) 380 ml, large dual cartridge.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The device in question is Lascod Impression Materials. The study proving its compliance refers to performance testing and biocompatibility testing against established standards.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ISO 4823:2015 & ISO 10993) | Reported Device Performance (Lascod Impression Materials) |
|---|---|
| Consistency | Pass |
| Working time | Pass |
| Mixing time | Pass |
| Detail Reproduction | Pass |
| Compatibility with Gypsum | Pass |
| Linear Dimensional Change | Pass |
| Elastic Recovery | Pass |
| Strain in Compression | Pass |
| Shore A Hardness | Pass |
| Shelf Life | 3 Years |
| Cytotoxicity | Pass |
| Irritation | Pass |
| Sensitization | Pass |
Study Details:
The provided document describes a 510(k) Premarket Notification for Lascod Impression Materials, asserting its substantial equivalence to a predicate device (HySil Impression Materials, K170736). The "study" mentioned refers to the performance and biocompatibility testing conducted to demonstrate this equivalence.
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for the performance tests (e.g., how many samples were tested for consistency, detail reproduction, etc.).
- The data provenance is not explicitly stated as "country of origin of the data" or "retrospective/prospective." However, the tests were conducted to comply with international standards (ISO 4823:2015 and ISO 10993), implying a controlled laboratory setting. Given that Lascod Spa is based in Florence, Italy, it's reasonable to infer that the testing was either conducted in Italy or by accredited labs adhering to international standards. The testing described is prospective in nature, as it's for premarket notification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable in the context of this device. The "ground truth" for impression materials is not typically established by human expert consensus but rather by objective physical and chemical measurements against industry-defined standards (ISO 4823:2015). The "acceptance criteria" are the physical and chemical thresholds defined by the ISO standard.
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Adjudication method for the test set:
- Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes. For material performance testing, the "adjudication" is inherent in the measurement process itself, where tests are performed according to a defined standard protocol, and results are objectively measured and compared against specified limits. There is no mention of human adjudication in this context.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. An MRMC study is relevant for AI or diagnostic imaging devices where human readers interpret data. This submission is for an impression material, a physical dental device, and does not involve AI or human readers interpreting its output in a diagnostic capacity.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable, as the device is a physical impression material and not an algorithm or AI system.
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The type of ground truth used:
- The "ground truth" here is defined by international standards and specifications:
- ISO 4823:2015 "Dentistry Elastomeric Impression Materials": This standard defines the acceptable ranges and pass/fail criteria for physical properties like consistency, working time, detail reproduction, dimensional change, elastic recovery, strain in compression, and Shore A Hardness.
- ISO 10993 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": This standard defines the methods and criteria for biocompatibility testing, which includes cytotoxicity, irritation, and sensitization.
- The "ground truth" here is defined by international standards and specifications:
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The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning or AI model that requires a "training set."
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How the ground truth for the training set was established:
- This is not applicable, as there is no training set for this type of device. The "ground truth" for the device's performance is established by the specifications and test methods outlined in the aforementioned ISO standards, which represent a consensus of expert knowledge in dental materials science.
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May 5, 2020
Lascod Spa % Dave Yungvirt Official Correspondent Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K201184
Trade/Device Name: Lascod Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: Class II Product Code: ELW Dated: April 28, 2020 Received: May 1, 2020
Dear Dave Yungvirt:
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.
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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 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.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201184
Device Name Lascod Impression Materials
Indications for Use (Describe)
The Lascod family of silicone impression materials includes the brand names: Ghenesyl, Kromopan Sil are used by dentists to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define required interventions, and/or check their effectiveness.
The Ghenesyl Putty and Kromopan Sil Putty products are indicated for obtaining preliminary impressions for the two-step putty/wash and base for the sandwich technique. The impression can be electroplated.
The Ghenesyl Body and Kromopan Sil Body products are indicated for the two-step putty/wash and for the sandwich technique. The impression can be electroplated.
The Ghenesyl Mono and Kromopan Sil mono products are indicated for monophasic technique, though it can be used also with Super Light Body / Light Body / Regular Body wash silicones as support material inside individual impression tray or standard stainless-steel impression tray.
Kromopan Sil Bite and Oklurest used by dentists to take impressions of occlusal surfaces in order to confirm the occlusal surfaces onto the plaster models assembled on an articulator.
Kromopan Sil Bite and Oklurest and products are indicated for orthodontic occlusion registration keys for gnathological registrations, inter-maxillary registration keys for centered positions, eruptions and ectopic eruptions, registration for cephalometric analysis which also require subsequent scanning with CAD systems.
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) |
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510k Summary
| 1. Date | April 29, 2020 |
|---|---|
| 2. Submitter | Lascod Spa |
| Via L Longo 18-50019 | |
| Sesto Fiorentino | |
| Florence, Italy | |
| Phone: +39 055 4215768 | |
| E-mail: lascod.italy@lascod.it | |
| 3. Contact | Gualtiero Cozzi |
| General Manager | |
| Phone +39 055 4215768 | |
| 4. Submission Correspondent | Srinagesh Koushik Ph.D. RAC |
| Managing Partner | |
| BDRA Consulting LLC | |
| 1 Clearwater Court | |
| Damascus, MD 20872. | |
| Phone: 301-922-7231 | |
| Email: bdraconsulting@gmail.com | |
| 5. Predicate Device | HySil Impression Materials |
| 510k number | K170736 |
| Common Name | Impression Material |
| Classification Name | Material, Impression |
| Regulation Number | 21 CFR 872.3660 |
| Device Classification | Class II |
| Product Code | ELW |
6. Indications for Use
The Lascod family of silicone impression materials includes the brand names: Ghenesyl, Kromopan Sil are used by dentists to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define required interventions, and/or check their effectiveness.
The Ghenesyl Putty and Kromopan Sil Putty products are indicated for obtaining preliminary impressions for the two-step putty/wash and base for the sandwich technique. The impression can be electroplated.
The Ghenesyl Body and Kromopan Sil Body products are indicated for the two-step putty/wash and for the sandwich technique. The impression can be electroplated.
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The Ghenesyl Mono and Kromopan Sil mono products are indicated for monophasic technique, though it can be used also with Super Light Body / Light Body / Regular Body wash silicones as support material inside individual impression tray or standard stainlesssteel impression tray.
Kromopan Sil Bite and Oklurest used by dentists to take impressions of occlusal surfaces in order to confirm the occlusal surfaces onto the plaster models assembled on an articulator.
Kromopan Sil Bite and Oklurest and products are indicated for orthodontic occlusion registration, registration keys for gnathological registrations, inter-maxillary registration keys for centered positions, eruptions and ectopic eruptions, registration for cephalometric analysis which also require subsequent scanning with CAD systems.
7. Device Description
Lascod Impression Materials are addition-curing polyvinylsiloxane silicones. They exhibit excellent accuracy, maximum thixotropy, and hydrophilicity. Additional elastomeric properties include, fast in the mouth setting time, high resistance to tear, dimensional accuracy, and resistance to permanent deformation. The Lascod impression material product line boasts multiple different variants: hard and soft putty; heavy, regular, light and superlight body – all putties and bodies, are available both as normal and fast set; mono and bite. Putties are provided in 300 or 150 ml plastic jars. The body and the bite product lines, are usually offered in the standard (1: 1) 50 ml dual barrel cartridges. The Mono product line is provided in two forms; a standard (1: 1) 50 ml dual cartridge, and a (5: 1) 380 ml, large dual cartridge.
8. Performance testing and Shelf Life
Lascod Impression Materials have been tested and are compliant with the requirements of ISO 4823:2015 "Dentistry Elastomeric Impression Materials." Shelf Life testing demonstrated that the silicones could be stored for three years. The performance requirements that Lascod Silicones comply with are provided in Table 1.
9. Biocompatibility testing
The FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" was used to determine biocompatibility testing requirements. Cytotoxicity, Irritation, and Sensitization testing conducted demonstrate that the Lascod Impression Materials are biocompatible.
10. Substantial Equivalence
Lascod Impression Materials have identical intended use and highly similar indications for use as the predicate device. Biocompatibility testing demonstrated that both predicate and subject devices were safe for intended use. Performance testing demonstrated that both subject
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and predicate device complied with requirements of ISO 4823:2015 and are effective for the stated intended use. Based on the information presented above Lascod concludes that the Lascod Impression Materials are substantially equivalent to HySil Silicones.
| Descriptiveinformation | Predicate | Lascod Impression Material |
|---|---|---|
| Company | Osstem Implant Co., Ltd. | Lascod Spa |
| Device Name | HySil Impression Material | Lascod Impression Material |
| 510k number | K170736 | N/A |
| Classification | II | II |
| Regulation | 21 CFR 872.3660 | 21 CFR 872.3660 |
| Descriptiveinformation | Predicate | Lascod Impression Material |
| Product Code | ELW | ELW |
| Intended Use | To be placed on an impression tray (orinjected directly into the mouth,depending on the technique and device)and used to reproduce the structure ofpatient's teeth and gums. To providemodels for study and for production ofrestorative prosthetic devices. | The Lascod impression materials includes the brandnames: Ghenesyl, Kromopan Sil are used by dentiststo take the anatomical data of the patient's mouthand subsequently realize a plaster mold useful todiagnose problems, define required interventions,and/or check their effectiveness.Kromopan Sil Bite and Oklurest used by dentists totake impressions of occlusal surfaces in order toconfirm the surfaces onto the plaster modelsassembled on an articulator. The impression takenwith Oklurest and/or Kromopan Sil can be scannedand used for occlusal surfaces registration and otherdiagnostic evaluation with CAD systems. |
| Indications for Use | HySil Putty is to be used as preliminarymaterials for:• Two-step Putty-wash impressiontechnique• One-step Putty-wash impressiontechniqueHySil Heavy is to be used as heavy-bodied materials for:• One-step impression technique(simultaneous technique) using single ordual viscosities• Two-step impression technique usingdual viscosities• Functional impressions HySil Mono isto be used as a medium-bodied tray orsyringeable impression materialfor: | The Lascod impression materials includes the brandnames: Ghenesyl, Kromopan Sil are used by dentiststo take the anatomical data of the patient's mouthand subsequently realize a plaster mold useful todiagnose problems, define required interventions,and/or check their effectiveness.The Ghenesyl Putty and Kromopan Sil Putty productsare indicated for obtaining preliminary impressions forthe two-step putty/wash and base for the sandwichtechnique. The impression can be electroplated.The Ghenesyl Body and Kromopan Sil Body productsare indicated for the two-step putty/wash and for thesandwich technique. The impression can beelectroplated. |
| 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 HySil 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 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 HySil Bite is used for impression as below. Taking occlusal surfaces | The Ghenesyl Mono and Kromopan Sil mono products are indicated for monophasic technique, though it can be used also with Super Light Body / Light Body / Regular Body wash silicones as support material inside individual impression tray or standard stainless-steel impression tray.Kromopan Sil Bite and Oklurest used by dentists to take impressions of occlusal surfaces in order to confirm the occlusal surfaces onto the plaster models assembled on an articulator.Kromopan Sil Bite and Oklurest and products are indicated for for orthodontic occlusion registration, registration keys for gnathological registrations, inter-maxillary registration keys for centered positions, eruptions and ectopic eruptions, registration for cephalometric analysis which also require subsequent scanning with CAD systems. | |
| Materials | Vinylpolysiloxane | Vinylpolysiloxane |
| Performance Testing | ||
| Standard | ISO 4823:2015 | ISO 4823:2015 |
| Type | Type 0 and Type 3 | Type 0, 1, 2 and 3 |
| Consistency | Pass | Pass |
| Working time | Pass | Pass |
| Mixing time | Pass | Pass |
| Detail Reproduction | Pass | Pass |
| Compatibility withGypsum | Pass | Pass |
| Linear DimensionalChange | Pass | Pass |
| Elastic Recovery | Pass | Pass |
| Strain inCompression | Pass | Pass |
| Shore A Hardness | Pass | Pass |
| Shelf Life | 3 Years | 3 Years |
| Biocompatibility | ISO 10993 | ISO 10993 |
| Cytotoxicity | Pass | Pass |
| Irritation | Pass | Pass |
| Sensitization | Pass | Pass |
Table 1: Substantial Equivalence
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11. Conclusion:
Comparison results demonstrate that the specifications and performance of the device are same as the legally marketed predicate device.
Based on the same intended use, similar indications for use, technological characteristics, and chemical properties between HySil Silicones and Lascod Silicones, Lascod concludes that Lascod Impression Materials are substantially equivalent to HySil Silicones.
§ 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).