Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a dental cement and its physical properties, with no mention of AI or ML.

Therapeutic

No.
The device is a dental luting agent used for temporary cementation of dental prosthetics, which is not a therapeutic function.

Diagnostic

No
The device is described as a dental luting agent for temporary cementation, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "dental luting cement" with "active ingredients of zinc oxide," indicating it is a physical substance, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
FixTemp Cement's Function: FixTemp Cement is a dental luting agent used to temporarily or semi-permanently hold dental prosthetics (crowns, bridges, implants) in place. It is applied directly to the teeth and prosthetics, not used to analyze samples from the body.
Lack of Diagnostic Purpose: The intended use and device description clearly state its purpose is mechanical fixation, not diagnosis or providing information about a patient's health status based on biological samples.

The information provided about the device's performance metrics (working time, film thickness, compressive strength) further supports its function as a material for dental procedures, not a diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

FixTemp ™ Cement is a dental luting agent indicated for:

temporary cementation of provisional crowns and bridges,
cementing of semi-permanent implants.

The intended use of the Fixtemp Cement is as a dental luting agent for use in interim dental restorations to retain temporary restorations.

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

EMA

Device Description

The Fixtemp Cement is designed as a luting cement for temporary dental applications. This dental cement having the active ingredients of zinc oxide does not include Eugenol. This lack of Eugenol does not reduce structural properties but allows a choice among healthcare professionals where Eugenol can cause objectionable results.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

all human teeth
all human teeth, except allergies

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Testing has confirmed this device meets its product specification. A series of factory tests are conducted to verify the intended signals are accurate and can maintain performance over its useful life. Testing has established this device is equal to predicate medical device in terms of working time, film thickness, and compressive strength (see comparison table).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Film Thickness (ISO 3107): Less than 20 µm
Setting Time (ISO 3107): Approx. 4 - 7 min
Compressive strength (ISO 3107): More than 8MPa
Working time: More than 1 min

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.

K110759

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

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

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

June 4, 2015

Exacta Dental Direct Inc. c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 60803

Re: K142446

Trade/Device Name: FixTemp Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: February 28, 2015 Received: March 6, 2015

Dear Mr. Keen:

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.

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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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.

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

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4. Indications for Use Statement

no 510(K) number assigned_ 510(K) Number (If k K142446 Name: FixTemp™ Cement

INDICATIONS FOR USE

FixTemp ™ Cement is a dental luting agent indicated for:

temporary cementation of provisional crowns and bridges, ●
cementing of semi-permanent implants. ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	XXX
------------------	-----

or

Over - The - Counter Use
	(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 14	Fixtemp Cement
---------	----------------

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5. 510(k) Summary

(per 21 CFR 807.92)

28 May 2015

Sponsor Mr. John Pankuch President

Exacta Dental Direct, Inc.

44780 Macomb Industrial Dr. Clinton Township, MI 48036 (800) 474-7665 416-253-6060 416-253-1911 Fax john@exactadental.com

Consultant

Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907-1659 203 329 2700 F 203 329 2345 rkeen@fda-complianceconsultants.com

Proprietary Name: Fixtemp Cement Common Name Fixtemp Cement Device Classification Name Dental Cement Classification Number: 21 CFR 872.3275 Product Code EMA Reviewing Group Dental Devices Panel Device Classification Class II Establishment registration No. Owner/Operator 9043538/ Registration # 1836392 Predicate Device K110759/ TempoCem / DMG USA, Inc. Trademark Notice: All Trademarks used other than those of Exacta Dental Direct, Inc. Exacta

Dental Direct, Inc. are registered to their respective owners.

Device Description

The Fixtemp Cement is designed as a luting cement for temporary dental applications. This dental cement having the active ingredients of zinc oxide does not include Eugenol. This lack of Eugenol does not reduce structural properties but allows a choice among healthcare professionals where Eugenol can cause objectionable results.

Indications For Use

FixTemp "10 Cement is a dental luting agent indicated for:

temporary cementation of provisional crowns and bridges, ●
cementing of semi-permanent implants.

Intended Use

The intended use of the Fixtemp Cement is as a dental luting agent for use in interim dental restorations to retain temporary restorations.

The scientific concept on which this device is based is the principle that a chemical reaction with zinc oxide forms an adhesive bond to act as a dental luting agent. This device functions by creating adhesion by chemical action.

Fixtemp Cement

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5. 510(k) Summary

(per 21 CFR 807.92)

Substantial Equivalence

Exacta Dental Direct, Inc. has determined that the Fixtemp Cement is substantially equivalent to the performance of a predicate Device. Fixtemp Cement is equal to this predicate. The differences between these devices are incidental and not significant. Both devices use similar technological characteristics and principles.

Testing

The Fixtemp Cement has benefited from design, development, testing and production procedures that conform to ISO 13485 Quality Systems.

Testing has confirmed this device meets its product specification. A series of factory tests are conducted to verify the intended signals are accurate and can maintain performance over its useful life. Testing has established this device is equal to predicate medical device in terms of working time, film thickness, and compressive strength (see comparison table).

Conclusion

There are no substantial differences between the Fixtemp Cement defined in this 510(k) submission and the stated predicate device. This device is equal to predicates currently used in other similar medical devices.

Exacta Dental Direct, Inc. continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting device to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

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Table 12-1 Substantially Equivalent Comparison to Predicate.doc comparison of the FixTemp ™ Cement to the predicate: TempoCem K110759

Description/Feature	Predicate Device TempoCem K110759	FixTemp Cement	Similarity	Difference	Comment
regulatory requirements
Description	temporary luting cement containing Eugenol that is based on zinc oxide in double cartridges	Eugenol free, temporary luting cement based on zinc oxide in double cartridges		Different	The absence of Eugenol simply eliminates the depression of sensitivity.
Classification Name:	Dental cement	Dental cement	Same		Both devices are dental cements
Classification	II	II	Same		Both devices are subject to same FDA regulation.
Regulation Number	21 CFR 872.3275 (a)	21 CFR 872.3275 (b)	Same		Both are subject to same FDA regulations
Product Code	EMB	EMA		Different	Product codes reflect presence or absence of Eugenol
Difference related to Eugenol	pleasant clove taste oil	Eugenol may inhibit future dental procedures		Different	Some practitioners prefer Eugenol and some avoid it.
Indications for Use	Indicated for temporary cementation of crowns and bridges or provisional cementation of crowns and bridges on implant abutments	Indicated for luting of temporary dental prosthesis (crowns, inlays, onlays)	Same
Intended Use	Temporary luting and cementation of temporary crowns and bridges	Temporary luting and cementation of temporary crowns and bridges	Same
What condition does it treat?	Applied directly on the temporary restoration and into the cavity.	Applied directly on the temporary restoration and into the cavity.	Same

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Table 12-1 Substantially Equivalent Comparison to Predicate.doc comparison of the FixTemp ™ Cement to the predicate: TempoCem K110759

Description/Feature	Predicate Device	FixTemp tm Cement	Similarity
	TempoCem K110759
characteristics
Compliance to standard	ISO3107	ISO3107	same
container	double cartridge or syringe	double cartridge or syringe	same
Dispenser	injector / syringe	injector / syringe	same
Paste Ratio	1:1 ?	1:1	same
Appearance	Homogeneous and
smoothly consistent	Homogeneous and
smoothly consistent	same
Film Thickness (ISO

                                     | Less than 20 µm                                                                                                                                   | Less than 20 µm                                                                                                  | same       |            |         |  |  |  |

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