(226 days)
TempoCem Clear is indicated for:
- · Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlays and onlays.
- · Temporary luting of temporary veneers.
- · Temporary or semipermanent luting of implant-borne dental prosthesis.
TempoCem Clear is a transparent, dual-curing, resin-based dental cement for the temporary or semipermanent cementing of provisional resin-based composite restorations (crowns, bridges, inlays, onlays, veneers) to a tooth and for temporary or semipermanent luting to an implant abutment. The cement consists of two pastes (base and catalyst) packaged in a double-barreled plastic syringe. The pastes are automatically mixed when dispensed through the single-use mixing tips supplied with the device.
The provided document is a 510(k) summary for a dental cement called TempoCem Clear. It does not contain information about a study proving the device meets specific acceptance criteria in the manner of a clinical efficacy trial with established benchmarks. Instead, it demonstrates substantial equivalence to a predicate device based on non-clinical performance data.
Here's an analysis based on the information provided, attempting to address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" against which the device performance is measured in a pass/fail manner. Instead, it compares the performance of TempoCem Clear to a predicate device (Telio CS Link) and references relevant ISO standards and FDA guidance. The "acceptance criteria" here are implied to be "comparable to the predicate device" or "within acceptable ranges for dental cements" as defined by the mentioned standards and guidance.
| Property (unit) | Acceptance Criteria (Implied) | TempoCem Clear (proposed device) | Predicate Device (Telio CS Link) |
|---|---|---|---|
| Solubility (µg/mm³) | Comparable to predicate/within standard (ISO 7405) | 19.0 ± 1.3 | 9.1 ± 0.6 |
| Water sorption (µg/mm³) | Comparable to predicate/within standard (ISO 7405) | 65.5 ± 2.0 | 77.3 ± 1.4 |
| Dimensional change after 7 days (%) | Comparable to predicate/within standard (ISO 7405) | 1.0 ± 0.1 | 1.7 ± 0.1 |
| Gel time, self-cure (s) | Comparable to predicate/within standard (ISO 7405) | 65 | 165 |
| Setting time, self-cure (s) | Comparable to predicate/within standard (ISO 7405) | 318 | 216 |
| Bonding strength for intended use | Good to satisfactory (comparable to predicate) | Good to satisfactory | Good to satisfactory |
| Film thickness (µm) | Comparable to predicate/within standard (ISO 7405) | 6 ± 1 | 39 ± 3 |
| Heat generated during setting (peak temp, °C) | Comparable to predicate/within standard (ISO 7405) | 43.1 ± 1.3 | 43.0 ± 0.5 |
| Compressive strength (MPa) | Comparable to predicate/within standard (ISO 7405) | 78 ± 8 | 43 ± 6 |
| Flexural strength (MPa) | Comparable to predicate/within standard (ISO 7405) | 5.4 ± 0.3 | 6.4 ± 0.2 |
| Shear bond strength (MPa) | Comparable to predicate/within standard (ISO 7405) | 8.7 ± 1.9 | 7.8 ± 2.0 |
| Fluoride release over 28 days (ppm) | (Unique to proposed device; predicate has no fluoride) | 8.0 ± 2.2 | No data |
| Biocompatibility | Demonstrated equivalence to predicate (cytotoxicity studies) | Equivalence demonstrated | (Predicate previously cleared) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (e.g., number of test specimens) for each of the physical and mechanical property tests. It states that "Physical and mechanical properties of TempoCem Clear were investigated and compared to the predicate device in accordance with FDA's 1998 Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (chemistry of the setting reaction, working and setting times, solubility, dimensional change, bonding strength, film thickness, heat generated during setting and biocompatibility)." This implies the tests were conducted in a laboratory setting, likely following standard test methodologies but the country of origin of the data is not specified (though the submitter information lists "DMG USA, Inc." in Massachusetts, USA). The data is by nature retrospective for the predicate device and newly generated for the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of testing described. The "ground truth" for physical and mechanical properties is established by standardized laboratory measurements rather than expert human interpretation. Biocompatibility "ground truth" is established via cytotoxic assays, not expert panels.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication for these types of non-clinical, quantitative tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a dental cement, not an AI-assisted diagnostic device. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical and mechanical properties, the "ground truth" is derived from direct measurements using established laboratory test methods (e.g., measuring solubility, strength, etc.) as outlined in the FDA guidance and ISO standards (e.g., ISO Standard 7405).
For biocompatibility, the ground truth is established through cytotoxicity studies, not expert consensus or pathology in a clinical setting.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff entwined with a serpent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2016
Dmg Usa, Inc. % Pam Papineau Consultant, President Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave Ayer, Massachusetts 01432
Re: K160443
Trade/Device Name: Tempocem Clear Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: August 30, 2016 Received: September 2, 2016
Dear Pam Papineau:
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.
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
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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,
Susan Runno DDS, MA
Tina Kiang, PhD Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name TempoCem Clear
Indications for Use (Describe)
TempoCem Clear is indicated for:
- · Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlays and onlays.
- · Temporary luting of temporary veneers
Type of Use (Select one or hoth, as annlicable)
- · Temporary or semipermanent luting of implant-borne dental prosthesis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------- |
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Section 5 - 510(k) Summary
- Submitter Information DMG USA, Inc. 23 Frank Mossberg Drive Attleboro, MA 02703, USA Phone: (508) 226-5660 Fax: (508) 226-7528
Contact Person: Pamela Papineau, RAC (US, EU, CAN) Phone: (978) 772-3552 Fax: (978) 796-5460 E: delphimdc@comcast.net
Date prepared: 27 September 2016
-
Device Name Name of device: TempoCem Clear Common name: Temporary dental cement Requlation number: 21 CFR 872.3275(b) Classification name: Dental Cement Regulatory device class: II Product code: EMA
-
Predicate Device
Primary predicate: Telio CS Link Systemp.link (K042846). Reference predicate: Telio CS Cem Implant (K120432).
4. Device Description
TempoCem Clear is a transparent, dual-curing, resin-based dental cement for the temporary or semipermanent cementing of provisional resin-based composite restorations (crowns, bridges, inlays, onlays, veneers) to a tooth and for temporary or semipermanent luting to an implant abutment. The cement consists of two pastes (base and catalyst) packaged in a double-barreled plastic syringe. The pastes are automatically mixed when dispensed through the single-use mixing tips supplied with the device.
5. Indications for Use
- · Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlavs and onlays.
- · Temporary luting of temporary veneers.
- · Temporary or semipermanent luting of implant-borne dental prosthesis.
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6. Comparison to the Predicate Device
A comparison of TempoCem Clear with the primary predicate device indicates the following similarities and differences.
| Definition orProperty [unit] | TempoCem Clear(proposed device)(K160443) | Telio CS Link(predicate device)(K042846) |
|---|---|---|
| Common name | Temporary dental cement | Temporary dental cement |
| Classification name | Cement, Dental21 CFR 872.3275 (b) | Cement, Dental21 CFR 872.3275 (b) |
| Product code | EMA | EMA |
| Indications for Use | Temporary or semipermanentluting of temporary andpermanent crowns, bridges,inlays and onlays.Temporary luting of temporaryveneers.Temporary or semipermanentluting of implant-borne dentalprosthesis. | Temporary cementation ofprovisional restorations.The product has been designedto remain in the mouth for amaximum of 6 weeks. |
| Composition | Glass filling material in a matrixof multifunctionalmethacrylates. Catalyst,stabilizer, additives. Free frommethyl methacrylate andperoxides. Percentage of filler:$40 wt % = 22 vol.% (0.02 -2.5 μm)$ . | Telio CS Link is composed ofbismethacrylates (56 wt.%)and fillers (43 wt.%). Initiators,stabilizers and pigments areadditional ingredients. |
| Curing mechanism | Dual-curing | Dual-curing |
| Maximum solubilitymeasured as watersolubility, dual-cure[µg/mm³] | $19.0 ± 1.3$ | $9.1 ± 0.6$ |
| Water sorption, dual-cure [µg/mm³] | $65.5 ± 2.0$ | $77.3 ± 1.4$ |
| Dimensional changeafter 7 days, dual-cure[%] | $1.0 ± 0.1$ | $1.7 ± 0.1$ |
| Gel time, self-cure [s] | 65 | 165 |
| Setting time, self-cure,measured as finalsetting time, excluding30 s mixing time [s] | 318 | 216 |
| Bonding strength forintended use, dual-cure | Good to satisfactory | Good to satisfactory |
| Film thickness, dual-cure [µm] | $6 ± 1$ | $39 ± 3$ |
| Amount of heatgenerated during | $43.1 ± 1.3$ | $43.0 ± 0.5$ |
| Definition orProperty [unit] | TempoCem Clear(proposed device)(K160443) | Telio CS Link(predicate device)(K042846) |
| setting (dual-cure),measured as peakpolymerizationtemperature [°C] | ||
| Compressive strength,dual-cure [MPa] | 78 ± 8 | 43 ± 6 |
| Flexural strength, dual-cure [MPa] | 5.4 ± 0.3 | 6.4 ± 0.2 |
| Shear bond strength,dual-cure [MPa] | 8.7 ± 1.9 | 7.8 ± 2.0 |
| Fluoride release,measured ascumulative value over28 days, dual-cure[ppm] | 8.0 ± 2.2 | No data(does not contain NaF) |
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TempoCem Clear is similar to the predicate device Telio CS Link in that they are both automixing, transparent, dual-curing temporary resin dental cements to be used for cementing restorations such as crowns, bridges, inlays and onlays. The devices have substantially equivalent physical and mechanical properties.
TempoCem Clear is different from the predicate device in that it contains sodium fluoride. The subject and predicate devices have slightly different Indications for Use language. The Indications for Use for Telio CS Link do not mention, but do not exclude, the use for specific restorations (temporary and permanent crowns, bridges, inlays, onlays, and veneers). The Intended Use for Telio CS Link as presented in the K042846 Summary was: "For the temporary cementation of temporary inlays, onlays, partial crowns, crowns or bridges." The differences in the Indications for Use affect neither the Intended Use nor substantial equivalence.
The reference predicate device, Telio CS Cem Implant, has the same FDA Product Code (EMA= Dental cement) as TempoCem Clear. Telio CS Cem Implant is a selfcuring resin cement with lightcuring option for the esthetic, temporary, reversible / semi-permanent cementation of restorations on implant abutments. The Indications for Use for Telio CS Cem Implant ("Reversible/semi-permanent cementation of longterm temporary and permanent restorations on implant abutments") are similar to the specific Indication for Use for TempoCem Clear ("Temporary or semipermanent luting of implant-borne dental prosthesis."). The composition of Telio CS Cem Implant (bismethacrylates (approx. 52 %wt.) and fillers (approx. 46 %wt.). Initiators, stabilizers, auxiliaries and piqments are additional components.) is substantially equivalent to TempoCem Clear. Thus TempoCem Clear is similar to the reference predicate Telio CS Cem Implant in composition, curing and indications.
7. Non-Clinical Performance Data
Physical and mechanical properties of TempoCem Clear were investigated and compared to the predicate device in accordance with FDA's 1998 Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (chemistry of the
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setting reaction, working and setting times, solubility, dimensional change, bonding strength, film thickness, heat generated during setting and biocompatibility), Comparative data relevant for temporary, dual-curing cements demonstrate substantial equivalence of TempoCem Clear to the predicate device, Telio CS Link.
The biocompatibility testing was performed according to the FDA 1998 Guidance and the following consensus standard:
- ISO Standard 7405 Second edition (2008): Dentistry Evaluation of biocompatibility of medical devices used in dentistry
Equivalence in biocompatibility to the predicate device was demonstrated in cytotoxicity studies.
In addition, TempoCem Clear can be compared to other currently marketed dental products also manufactured by DMG: Luxatemp Ultra (K101710), Luxatemp / Luxatemp-Solar (K013674) and Luxatemp Automix (K924830). These dual-cure or auto-cure devices are not temporary cements, but have many similarities in curing mechanism and composition with TempoCem Clear. For example, the same auto-cure system and many of the same resin and pigment components are used in TempoCem Clear. The Luxatemp products have been marketed world-wide for over 25 years, and there is considerable clinical experience with these products and their components. This experience provides further evidence for the biocompatibility of the materials in TempoCem Clear.
8. Clinical Performance Data
Not applicable. Clinical performance testing has not been performed for the proposed device.
9. Conclusions
.
Based on the device Indications for Use, composition and physical / mechanical properties, TempoCem Clear has been shown to be substantially equivalent to the predicate device.
§ 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.