(77 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a dental liner/base, with no mention of AI or ML technologies.
No
This device is a dental liner/base material used to prepare cavities for restoration, which is a structural rather than a therapeutic function.
No
The device is described as a dental liner/base material used to line cavity preparations before restoration, which is a treatment or restorative function, not diagnostic.
No
The device description clearly states it is a "light-cured, calcium and fluoride releasing, radiopaque dental liner/base material" which is a physical substance, 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 "line cavity preparations before restoration." This is a direct treatment or preparation step within the mouth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a material used for dental procedures.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for diagnosis.
- Bench Testing: The performance studies describe bench testing of material properties (setting time, strength, etc.), which are relevant to its function as a dental liner/base, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin. Lime-Life II is used to line cavity preparations before restoration.
Product codes (comma separated list FDA assigned to the subject device)
76 EJK, EJK
Device Description
Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin. Lime-Lite II is used to line cavity preparations before restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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)
The following test results demonstrate that Lime-Lite II performs as intended:
Light Cure Setting Time: 5 minutes
Depth of cure: 2 mm
Compressive Strength: 238 +/- 33 MPa, 34,500 +/- 4785 p.s.i.
Flexural Strength: 57 +/- 10 MPa, 8265 +/- 1450 p.s.i.
Density: 1.620 g/ml
pH: 10 +/- 0.5
Water absorption: 0.025 mg/mm³/ 25µg/ mm³
Shelf-life: Two years
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
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.
0
PORATION
MAR - 5 2012
80 Oakland Street Watertown, MA 02472 USA
TEL: 617-926-6666 FAX: 617-926-6262 Pulpdent@pulpdent.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street Watertown, MA 02472 USA
Telephone: Fax: Email.
617-926-6666 617-926-6262 ken@pulpdent.com
DEVICE:
Trade Name: Lime-Lite II Classification Name: Calcium hydroxide cavity liner. FDA Product Code: 76 EJK, 21 CFR Part 872.3250
PREDICATE DEVICES:
Pulpdent Limelight Scientific Pharmaceuticals Fluoroseal Dentin Sealer and Cavity Liner
DESCRIPTION AND INTENDED USE:
Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin. Lime-Lite II is used to line cavity preparations before restoration.
COMPARISON WITH PREDICATE PRODUCTS:
Lime-Lite II is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.
| PRODUCT | DESCRIPTION | INTENDED USE | COMPOSITION |
|---|---|---|---|
| Lime-Lite II | Calcium and fluoride releasing, | ||
| light cured, radiopaque dental | |||
| liner/base material in a | |||
| urethane dimethacrylate base. | Line cavity preparations before | ||
| restoration. | Acrylate resins | ||
| Hydroxyapatite | |||
| Calcium hydroxide and/or | |||
| Calcium phosphate tribasic | |||
| Photo-chemistry | |||
| Glass filler | |||
| Pulpdent Limelight | |||
| K953079 | Calcium and fluoride releasing, | ||
| light cured, radiopaque dental | |||
| liner/base material in a | |||
| urethane dimethacrylate base. | Line cavity preparations before | ||
| restoration. | Acrylate resins | ||
| Calcium hydroxide | |||
| Photo-chemistry | |||
| Glass filler | |||
| Scientific Pharmaceuticals | |||
| Fluoroseal | |||
| K860633 | Calcium and fluoride releasing, | ||
| light cured, radiopaque dental | |||
| liner/base material in a resin | |||
| base. | Line cavity preparations before | ||
| restoration | Resin Base | ||
| Hydroxyapatite | |||
| Photo-chemistry |
1
PULPDENT CORPORATION
80 Oakland Street Watertown, MA 02472 USA
TEL: 617-926-6666 FAX: 617-926-6262 Pulpdent@pulpdent.com
Summary of Performance Testing - Bench
The following test results demonstrate that Lime-Lite II performs as intended:
| Light Cure Setting Time | 5 minutes |
| Depth of cure | 2 mm |
| Compressive Strength | 238 ± 33 MPa, 34,500 ± 4785 p.s.i. |
| Flexural Strength | 57 ± 10 MPa, 8265 ± 1450 p.s.i. |
| Density | 1.620 g/ml |
| pH | 10 ± 0.5 |
| Water absorption | 0.025 mg/mm³/ 25µg/ mm³ |
| Shelf-life | Two years |
SAFETY AND EFFECTIVENESS:
From the above comparisons, the bench testing and the organizational experience with Lime-Lite, it can be concluded that Lime-Lite II is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.
The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3250 and CFR 872.3260 and have been used successfully by dental professionals for more than ten years with no reports of adverse events.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Mr. Kenneth J. Berk Director of Research Pulpdent Corporation 80 Oakland Street Watertown. Massachusetts 02472
MAR - 5 2012
Re: K113711
Trade/Device Name: Lime-Lite™ II Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Codes: EJK Dated: December 13, 2011 Received: December 21, 2011
Dear Mr. Berk:
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.
3
Page 2 - Mr. Berk:
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" (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,
Nh for
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
4
Indications for Use
510(k) Number (if known): K 113711
Device Name: Pulpdent Lime-Lite™ II
Indications For Use:
Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin. Lime-Life II is used to line cavity preparations before restoration.
Prescription Use X . (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Roys
(Division Sign-Off) 'vision of Anesthesiology, General Hospital iection Control, Dental Devices
Page 1 of 1
510(k) Number:
1-10