Kromopan type 1 and 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Device Description

Kromopan type 1, Kromopan type 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions.

AI/ML Overview

The provided text describes dental impression materials (alginates) and their compliance with established standards, not an AI/ML powered medical device. Therefore, the information requested in the prompt, such as acceptance criteria based on performance metrics, sample sizes for test and training sets, expert qualifications, and AI-specific study details, is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices through chemical composition, intended use, and adherence to ISO standards and internal performance criteria for traditional material properties.

However, I can extract and present the relevant information regarding the performance and acceptance criteria for these dental alginate materials based on the provided text, and explain why other requested details are not present.

Acceptance Criteria and Device Performance (for Dental Alginates)

Since this is not an AI/ML device, performance is measured against established material standards and internal specifications, rather than clinical metrics like sensitivity or specificity.

Acceptance Criteria Category	Specific Criteria (Standard/Internal Spec)	Reported Device Performance
International Standards	ISO 1563:1990 - 4.1 / 6.2 (Powder)	Complies with ISO 1563:1990 standards
	ISO 1563:1990 - 4.3 / 6.2 (Mixed material)	Complies with ISO 1563:1990 standards
	ISO 1563:1990 - 4.4 (Mixing Time)	Complies with ISO 1563:1990 standards
	ISO 1563:1990 - 4.5 / 6.3 (Total working time)	Complies with ISO 1563:1990 standards
	ISO 1563:1990 - 4.6 / 6.4 (Reproduction of detail)	Complies with ISO 1563:1990 standards
	ISO 1563:1990 - 4.7 / 6.5 (Recovery from deformation)	Complies with ISO 1563:1990 standards
	ISO 1563:1990 - 4.8 / 6.6 (Strain in compression)	Complies with ISO 1563:1990 standards
	ISO 1563:1990 - 4.9 / 6.7 (Compressive strength)	Complies with ISO 1563:1990 standards
Lascod Internal Criteria	LAVSCOD PVPF001 - 3.8 (setting time)	Complies with LASCOD performance criteria
	LAVSCOD PVPF001 - 3.3 (first color change & second color change)	Complies with LASCOD performance criteria
	LAVSCOD PVPF001 - 3.11 (dimensional stability)	Complies with LASCOD performance criteria
	LAVSCOD PVPF001 - 3.5 (Flavor)	Complies with LASCOD performance criteria
	LAVSCOD PVPF001 - 3.6 (color after setting time)	Complies with LASCOD performance criteria

Why other requested details are not applicable or provided in this document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes the properties of dental impression materials. Performance is evaluated against published international standards (ISO) and the manufacturer's own internal standards for material properties (e.g., mixing time, dimensional stability, elastic recovery). These tests are typically conducted in a laboratory setting on samples of the material, not on a "test set" of patient data or clinical images. Therefore, concepts like data provenance (country, retrospective/prospective) and sample size in the context of clinical data are not relevant here. The ISO standards themselves define the number of specimens required for each test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- "Ground truth" in the context of material properties is established by objective measurements based on scientific principles and standardized testing procedures (e.g., using calipers for dimensional stability, rheometers for setting time). It does not involve expert clinical interpretation in the way AI/ML models are evaluated.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for material testing.
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:
- Not applicable. This is not an AI-powered device, nor does it involve "human readers" or "cases" in the diagnostic sense.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical dental material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for material properties is derived from physical and chemical measurements following highly standardized laboratory protocols (e.g., dimensional accuracy measured against a known standard, mechanical properties measured using calibrated instruments).
The sample size for the training set:
- Not applicable. This is a manufactured product, not a statistical model that requires a training set. The "training" for such a product involves R&D and manufacturing process validation.
How the ground truth for the training set was established:
- Not applicable.

In summary, the provided document is a 510(k) summary for traditional dental impression materials, focusing on demonstrating substantial equivalence to predicate devices and compliance with established material standards. It does not pertain to AI/ML powered devices, and thus the requested AI/ML specific information is not present.

Summary

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K121 S124

Section 5: 510(k) Summary

5.1. Submitter:

Lascod Spa. Via L. Longo18-50019 Sesto Fiorentino Florance, Italy Phone: +39 055 4215768 fax: +39 055 4210421

Gualtiero Cozzi General Manager Phone: +39 055 4215768 Email: fiesoli@lascod.it

5.3. Date of Summary:

5.4. Device:

· 5.2. Contact:

5.5. Predicate Devices:

Classification Name: Material, Impression

June18, 2012

Common Name: Chromatic Alginate Trade / Proprietary name: Alginor Classification Name: Material, Impression

Common Name: Chromatic Alginate Trade / Proprietary name: Kromopan

Common Name: Chromatic Alginate Trade/ Proprietary name: Alginelle type 1 Classification Name: Material, Impression

Common Name: Chromatic Alginate Trade/ Proprietary name: Alginelle type 2 Classification Name: Material, Impression

Common Name: Chromatic Alginate Trade/ Proprietary name: Millenium Classification Name: Material, Impression

Manufacturer: Lascod Spa, Italy. Device: Kromopan 1 510(k) Number: Pre-amendments Device Classification Names & Citations: 21 FR 872.3660, Impression Material, Class 2

Manufacturer: Lascod Spa, Italy. Device: Kromopan 2 510(k) Number: Pre-amendments Device Classification Names & Citations: 21 CFR 872.3660, Impression Material, Class 2

AUG 2 3 2012

ਟ-ਹ

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5.6. Intended Use:

Kromopan type 1, Kromopan type 2, Alginor type 1, Alginelle type 1, Alginelle type 2 and Millenium alginates are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

5.6. Substantial Equivalence Summary:

This submission is based on the preamendments device Kromopan. Alginor, Alginelle and Millenium are substantially equivalent to Kromopan because they all have the same intended use and are nearly identical in their chemical composition.

5.7. Technological Characteristics

All the alginates described in the premarket notification application (510k) have the following technological characteristics:

. Identical mechanism of action
. Identical dimensional stability 100 hours
. Highly similar preparation times
. Highly similar elastic recovery and accuracy
5.8. All LASCOD alginates comply with the recognized International Standards Organization guidance. Specifically the Powder with ISO 1563:1990- 4.1 / 6.2, Mixed material with ISO 1563:1990 - 4.3 / 6.2, Mixing Time ISO 1563:1990 -- 4.4, Total working time ISO 1563:1990 -4.5 /6.3, Reproduction of detail ISO 1563:1990 -4.6 /6.4, Recovery from deformation ISO 1563:1990 - 4.7 / 6.5, Strain in compression ISO 1563:1990 - 4.8 / 6.6, Compressive strength ISO 1563:1990- 4.9 /6.7.

Additionally, these Alginates also comply with the following LASCOD performance criteria: LAVSCOD PVPF001 -3.8(setting time), -3.3 (first color change & second color change), -3.11(dimensional stability), -3.5 (Flavor), and -3.6 (color after setting time).

5.9. LASCOD will update and include in this summary any other information deemed reasonably necessary by the FDA
5-2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 2 3 2012

LASCOD SpA C/O Mr. Blix Winston, MPA, MS ACMD Consulting, Limited Liability Company 2600 Mullinix Mill Road Mount Airy, Maryland 21771

Re: K121824

Trade/Device Names: Kromopan (type 1 and 2), Alginor (type 1), Alginelle (type 1 and 2), and Millenium Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: June 18, 2012 Received: June 21, 2012

Dear Mr. Winston:

We have reviewed your Section 5-10(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.

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Page 2- Mr. Winston

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 go to http://www.fda.gov/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" (21 CFR 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,

hifor

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Kromopan type 1 and 2, Alginor type 1, Alginelle type 1 and 2, Alginelle type 2, and Millenium

Indications for Use:

Prescription Use

AND/OR

Over-The- Counter Use

(Part 21 CFR 810 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THUS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rosser

v. General Hospital

510(k) Number:

Regulation Number and Section

§ 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).