(71 days)
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No
The summary describes a chemical compound (Calcium Hydroxide) used as a cavity liner and pulp capping agent. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a pulp capping agent and cavity liner, which are therapeutic applications in dentistry.
No
The device, Life 2, is described as a "hard setting Calcium Hydroxide cavity liner and pulp capping agent." Its intended use is for restorative techniques, which is a treatment function, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor a condition.
No
The device description clearly states it is a "hard setting Calcium Hydroxide cavity liner and pulp capping agent," which 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 as a "hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques." This describes a material used within the body during a dental procedure, not a test performed outside the body on a sample (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description details a "two-part, base/catalyst paste/paste system" packaged in tubes. This is consistent with a dental material applied directly to the tooth structure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, Life 2 is a dental material used in restorative dentistry, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Life 2 is a hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
Product codes (comma separated list FDA assigned to the subject device)
EJK
Device Description
Life 2 is a hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques. Life 2 is a two-part, base/catalyst paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Regular Set and Fast Set.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Kerr Corporation, Life
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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image is a logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized font, with a curved line above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are written in a smaller, sans-serif font. The logo is black and white.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: August 2001
Device Name:
- Trade Name -- Life 2 .
- Common Name Hard setting calcium hydroxide cavity lining and pulp capping agent .
- Classification Name -- Calcium hydroxide cavity liner, per 21 CFR § 872.3250 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, Life .
Device Description:
Life 2 is a hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques. Life 2 is a two-part, base/catalyst paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Regular Set and Fast Set.
Intended Use of the Device:
Life 2 is a hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
Substantial Equivalence:
Life 2 is substantially equivalent to other legally marketed devices in the United States. Life 2 functions in a manner similar to and is intended for the same use as the original Life formulation that is currently manufactured by Kerr Corporation.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2001
Ms. Colleen Boswell Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K012717
Trade/Device Name: Life 2 Regulation Number: 21 CFR 872.3250 Regulation Name: Hard Setting Calcium Hydroxide Cavity Lining and Pulp Capping Agent Regulatory Class: Class II Product Code: EJK Dated: August 13, 2001 Received: August 15, 2001
Dear Ms. Boswell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); 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.
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Page 2 - Ms. Boswell
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I
Indications for Use Statement
| Ver/ 3 - 4/24/96 | |
|---|---|
| Applicant: | Kerr Corporation |
| 510(k) Number (if known): | K012717 |
| Device Name: | Life 2 |
| Indications For Use: | |
| Life 2 is a hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Susan Runne
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K012717