K Number
K151526
Device Name
Zone, ZoneFree, Zone A1
Date Cleared
2015-09-10

(94 days)

Product Code
Regulation Number
872.3275
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zone/Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements used for the cementation of temporary restorations.
Device Description
Zone, Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements. They are self-cure materials that set by a reaction between Zinc Oxide present in the catalyst paste and Dimer Acid present in the base paste. The proposed temporary cements are to be placed in the mouth for up to 30 days. Zone comes in three options - the standard Zone cement, Zone A1 shade cement, and ZoneFree a translucent variant. The design of ZoneFree is based on Zone, but uses only small particle size Zinc Oxide to achieve both translucency and color-blending properties. Zone and Zone A1 are designed to set one minute slower than ZoneFree. The delivery systems include an automix syringe, 15 ml syringe, and a unit dose. Zone and Zone A1 are also available in a tube delivery.
More Information

Not Found

No
The device description and performance studies focus on the material properties and physical performance of a temporary dental cement, with no mention of AI or ML technologies.

No
The device is a temporary dental cement used for the cementation of temporary restorations, which is not considered a therapeutic device designed to treat a disease or condition.

No

The device is a temporary dental cement used for the cementation of temporary restorations, not for diagnosing any condition.

No

The device description clearly states it is a Zinc Oxide Non-Eugenol temporary cement, which is a physical material, not software. The performance studies also focus on material properties like work time, set time, and compressive strength.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the "cementation of temporary restorations" in the mouth. This is a direct application within the body for a therapeutic purpose (holding a restoration in place), not for examining specimens from the body to provide diagnostic information.
  • Device Description: The description details a material that sets by a chemical reaction and is placed in the mouth. This aligns with a dental material used for temporary fixation.
  • Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting for testing.

Therefore, Zone/Zone A1 and ZoneFree are classified as dental materials used for temporary cementation, not as In Vitro Diagnostic devices.

N/A

Intended Use / Indications for Use

Zone/Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements used for the cementation of temporary restorations .

Product codes (comma separated list FDA assigned to the subject device)

EMA

Device Description

Zone, Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements. They are self-cure materials that set by a reaction between Zinc Oxide present in the catalyst paste and Dimer Acid present in the base paste. The proposed temporary cements are to be placed in the mouth for up to 30 days. Zone comes in three options - the standard Zone cement, Zone A1 shade cement, and ZoneFree a translucent variant. The design of ZoneFree is based on Zone, but uses only small particle size Zinc Oxide to achieve both translucency and color-blending properties. Zone and Zone A1 are designed to set one minute slower than ZoneFree. The delivery systems include an automix syringe, 15 ml syringe, and a unit dose. Zone and Zone A1 are also available in a tube delivery.

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

Licensed 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)

Non-clinical performance data included testing for Work time, Set time, Film thickness, Arsenic Content and Compressive Strength, as well as Biocompatibility and Stability testing. The following standards were utilized for the non-clinical performance testing: Guidance for Industry and FDA Staff: Dental Cements -Premarket Notification [510(k)] Submissions, August 18, 1998; ISO 10993-1: 2009 Biological evaluation of medical devices; ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in . Vitro Cytotoxicity, and ISO 3107:2011 Dentistry -- Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements.

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.

K003658

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

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

September 10, 2015

Sybron Dental Specialties Ms. Courtney Clark Regulatory Affairs Manager 1717 W. Collins Avenue Orange, CA 92867

Re: K151526

Trade/Device Name: Zone, Zone A1, Zonefree Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 12, 2015 Received: August 13, 2015

Dear Ms. Clark:

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.

1

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K151526

Device Name Zone/Zone A1 and ZoneFree

Indications for Use (Describe)

Zone/Zone A 1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements used for the cementation of temporary restorations .

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

SECTION 5. 510(k) SUMMARY for Zone/Zone A1 and ZoneFree Temporary Dental Cement

1. Submitter Information:

Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

Contact Person:Courtney Clark
Telephone Number:714-516-7426
Fax Number:714-516-7472

Date Prepared: June 5, 2015

2. Device Name:

Proprietary Name:Zone, Zone A1 and ZoneFree
--------------------------------------------------
  • Classification Name: Cement, Dental
  • CFR Number: 872.3275 ●
  • Device Class: ଧ .
  • Product Code: . EMA

Predicate Device: 3.

.

Zone, Zone A1 and ZoneFree are substantially equivalent to the legally marketed device Temp-Bond NE 2 Temporary Zinc Oxide Non-Eugenol Cement (K003658) cleared on January 4, 2001, product code EMA.

4. Description of Device:

Zone, Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements. They are self-cure materials that set by a reaction between Zinc Oxide present in the catalyst paste and Dimer Acid present in the base paste. The proposed temporary cements are to be placed in the mouth for up to 30 days. Zone comes in three options - the standard Zone cement, Zone A1 shade cement, and ZoneFree a translucent variant. The design of ZoneFree is based on Zone, but uses only small particle size Zinc Oxide to achieve both translucency and color-blending properties. Zone and Zone A1 are designed to set one minute slower than ZoneFree. The delivery systems include an automix syringe, 15 ml syringe, and a unit dose. Zone and Zone A1 are also available in a tube delivery.

Accessories Used with ZoneManufacturer of Accessory
Automix tipsSulzer Mixpac AG
Ruetistrasse 7
Haag Sankt
gallen, Switzerland 9469

4

  • ડ. Indications for Use:
    Zone/Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements used for the cementation of temporary restorations.

    1. Description of Substantial Equivalence:
      Technological Characteristics

The designs of Zone, Zone A1 and ZoneFree are similar to the predicate Temp-Bond NE 2 (K003658), as they are all Zinc Oxide Non-Eugenol temporary cements based on reaction between Zinc Oxide and Dimer Acid. They are all considered Type I, class 2B cements compliant to ISO 3107 Dentistry -- Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements. Although the chemical compositions of the subject and predicate devices are not identical, they have been determined to be substantially equivalent in terms of mechanical performance and biocompatibility.

Non-Clinical Performance Data

Non-clinical performance data included testing for Work time, Set time, Film thickness, Arsenic Content and Compressive Strength, as well as Biocompatibility and Stability testing. The following standards were utilized for the non-clinical performance testing:

  • . Guidance for Industry and FDA Staff: Dental Cements -Premarket Notification [510(k)] Submissions, August 18, 1998
  • ISO 10993-1: 2009 Biological evaluation of medical devices ●
  • ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in . Vitro Cytotoxicity
  • ISO 3107:2011 Dentistry -- Zinc oxide/eugenol cements and zinc oxide/non-● eugenol cements

| Element | Predicate Temp-Bond NE 2 | Proposed Zone/Zone
A1/ZoneFree |
|---------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K003658 | To be assigned |
| Trade Name | Temp-Bond NE 2 | Zone/Zone A1/ZoneFree
Temporary Cement |
| Target Users | Licensed dental professionals | Licensed dental professionals |
| Device Description | Temp-Bond NE is a non-eugenol
temporary cement used for the
cementation of temporary
restorations. | Zone/Zone A1 and ZoneFree are
Zinc Oxide Non-Eugenol
temporary cements used for the
cementation of temporary
restorations. |
| Common Name | Dental Zinc Oxide Non-eugenol
Cements | Dental Zinc Oxide Non-eugenol
Cements |
| Classification Name | Cement, Dental | Cement, Dental |
| Class | 2 | 2 |
| Product Code | EMA | EMA |
| Storage | Ambient Temperature | Ambient Temperature |
| Curing Mechanism | Reaction of Zinc Oxide and Dimer | Reaction of Zinc Oxide and Dimer |

Table 5.1: Predicate and Proposed Device Comparison Table

5

ElementPredicate Temp-Bond NE 2Proposed Zone/Zone A1/ZoneFree
Material CompatibilityAcid
Biocompatibility meets requirementsDimer Acid
Biocompatibility meets requirements
Shelf Life24 months based on real time data24 months based on real time data
Work timeMinimum of 90 secondsMinimum of 90 seconds
Set time per ISO 3107PassPass
Film thickness per ISO 3107PassPass
Arsenic content per ISO 3107PassPass
Compressive strength per ISO 3107PassPass
Configurations/DimensionsAutomix syringe, tubes, unit doseAutomix syringe, 15 ml syringe, tubes, unit dose

Clinical Performance Data

Clinical performance testing has not been performed for Zone/Zone A1 or ZoneFree.

Conclusion as to Substantial Equivalence

The technological characteristics of Zone/Zone A1 and ZoneFree are very similar to the predicate, TempBond NE 2 (K003658), and the intended use is the same. Based on the results of internal stability, performance based on ISO 3701, and biocompatibility testing, Zone/Zone A1 and ZoneFree are substantially equivalent to the predicate, TempBond NE 2 (K003658).