ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2

K121824 · Lascod Spa · ELW · Aug 23, 2012 · Dental

Device Facts

• Record ID: K121824
• Device Name: ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2
• Applicant: Lascod Spa
• Product Code: ELW · Dental
• Decision Date: Aug 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

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.

Device Story

Irreversible hydrocolloid impression material; used by dentists to capture anatomical data of patient's mouth; creates plaster molds for diagnosis, treatment planning, and restorative prosthetic fabrication (inlays, dentures). Material is mixed and applied to patient's mouth; sets to form negative impression; used to cast positive plaster models. No electronic or software components.

Clinical Evidence

Bench testing only. Compliance with ISO 1563:1990 standards for powder, mixed material, mixing time, working time, reproduction of detail, recovery from deformation, strain in compression, and compressive strength. Additional performance testing per LASCOD internal criteria (PVPF001) for setting time, color change, dimensional stability, flavor, and color after setting.

Technological Characteristics

Irreversible hydrocolloid impression material. Complies with ISO 1563:1990 standards for physical properties. Performance criteria include 100-hour dimensional stability, specific setting times, and color-changing properties. No energy source, software, or connectivity.

Indications for Use

Indicated for dental patients requiring anatomical impressions for diagnostic study models or production of restorative prosthetic devices, including gold inlays and dentures.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Kromopan 1 (Pre-amendments)
• Kromopan 2 (Pre-amendments)

Submission Summary (Full Text)

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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: [phone] fax: [phone]

Gualtiero Cozzi General Manager Phone: [phone] Email: [e-mail]

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 [phone] or [phone] 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:

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.

Prescription Use

AND/OR

Over-The- Counter Use

(Part 21 CFR 810 Subpart D)

X

(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:**