(151 days)
Visalys® CemCore is a dual-curing, adhesive cementation and core build-up composite, which is intended to be used for: a) Permanent cementation of · crowns, bridges, inlays, veneers and adhesive bridges made of metal, ceramic, composite, hybrid and oxide ceramics • root posts and indirect core build-ups b) Composite for · adhesive core build-ups Visalys® CemCore Try In Paste is a water-soluble polyethylene glycol paste for shade matching: · To check the shade selected prior to permanent cementation with Visalys® CemCore. · For covering the cement joint to reduce a layer of inhibition.
Visalys® CemCore is a dual-curing composite containing fluoride for adhesive cementation of indirect restorations and root posts and can be used to fabricate radiopaque core build-ups and abutment fillings. Due to the Active-Connect-Technology (ACT) Visalys® CemCore includes an additional initiator system for the optimization of the adhesive bond. BPA or BPA precursors are not used in the manufacturing process of this device. Visalys® CemCore shall only be used in combination with self-etching Visalys® Tooth Primer. Visalys® Restorative Primer is recommended as the primer for the restoration surfaces. Visalys® CemCore is easy to use and has high adhesive strength and good flowability with stable consistency. Visalys® CemCore is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste should be mixed and dispensed directly from a double syringe with the corresponding mixing tips blue (MLø 3.2 mm). Visalys® CemCore Try in Paste serves to simulate the shade effect of the selected Visalys® CemCore shade on ceramic restorations and for covering the cement joint to reduce a layer of inhibition. The water-soluble paste corresponds in shade and translucence with the completely cured Visalys® CemCore. Visalys® CemCore Try In Paste is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste is dispensed from a syringe and syringe tip.
The provided text describes a 510(k) premarket notification for a dental device, Visalys® CemCore and Visalys® CemCore Try In Paste. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical performance testing results.
However, the document does not contain information about a study proving the device meets specific acceptance criteria related to AI/algorithm performance, nor does it refer to human reader studies, ground truth establishment by experts, or training/test set data for an AI system. The assessments are based on bench testing for mechanical properties, biocompatibility, and visual comparisons for shade consistency, all against established ISO or ASTM standards, or internal methods.
Therefore, I cannot fulfill the request as it pertains to AI/algorithm performance and human expert studies because such information is not present in the provided text. The device is a dental material, not an AI-powered diagnostic or assistance tool.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 8, 2019
Kettenbach GmbH & Co. KG Katja Simon Regulatory Affairs Manager Im Heerfeld 7 Eschenburg, 35713 De
Re: K191527
Trade/Device Name: Visalys CemCore, Visalys Cem Core Try In Paste Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 9, 2019 Received: August 12, 2019
Dear Katja Simon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191527
Device Name Visalys® CemCore Visalys® CemCore Try In Paste
Indications for Use (Describe)
Visalys® CemCore is a dual-curing, adhesive cementation and core build-up composite, which is intended to be used for: a) Permanent cementation of
· crowns, bridges, inlays, veneers and adhesive bridges made of metal,
ceramic, composite, hybrid and oxide ceramics
• root posts and indirect core build-ups
b) Composite for
· adhesive core build-ups
Visalys® CemCore Try In Paste is a water-soluble polyethylene glycol paste for shade matching:
· To check the shade selected prior to permanent cementation with Visalys® CemCore.
· For covering the cement joint to reduce a layer of inhibition.
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)
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Image /page/3/Picture/0 description: The image contains the logo for KETTENBACH. The logo consists of a blue square with six white circles arranged in a triangular pattern at the top. Below the circles, the word "KETTENBACH" is written in a bold, sans-serif font. Underneath the company name, the tagline "Simply intelligent" is displayed in a smaller, sans-serif font.
K191527 510(k) Summary
A. Name and address of manufacturer:
Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany Establishment Registration No.: 9681356 Owner/Operator Number: 9022134
Name, title and phone number of official correspondent:
Simon, Katja Requlatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail:_katja.simon@kettenbach.com
Name, title and phone number of U.S. Agent (Contact):
Roggenbau, Wilfried InterGest North America LLC. 400 Oser Ave., Suite 1650 Hauppauge, NY 11788 Phone: 631 5010500 ext Fax: 631 5011060 Email: roggenbauw@intergestna.com
Date of preparation:
October 30th, 2019
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Image /page/4/Picture/0 description: The image is a logo for KETTENBACH. The logo features a blue square with the word "KETTENBACH" in white letters. Above the word is a graphic of six white circles arranged in a triangular shape. Below the word is the phrase "Simply intelligent" in black letters. To the right of the blue square is a circled R symbol.
| B. Device Identification:Device Trade Name:Versions: | Visalys® CemCoreVisalys® CemCoreUniversal (A2/A3), Dark (A4), Opaque, Bleach,Translucent |
|---|---|
| Common Name: | Dual-curing, adhesive cementation and core build-upcomposite |
| Device Identification:Device Trade Name:Versions: | Visalys® CemCore Try In PasteVisalys® CemCore Try In PasteUniversal (A2/A3), Dark (A4), Opaque, Bleach,Translucent |
| Common Name: | Water-soluble polyethylene glycol paste for shadematching |
Classification of the device (Visalys® CemCore/Visalys® CemCore Try In Paste):
- Device Classification Name: Dental cement 1. Product Code: EMA 2. Product Code: EBF Device Classification No.: Part 872.3690 Panel: Dental Regulatory Status: Class II
tus:
DC
CH
C. Predicate devices:
| Applicant Product | Product Type | ProductCode | PredicateDevice | 510(k) No. | Product Code | Applicant |
|---|---|---|---|---|---|---|
| Visalys CemCore | Dental Cement | EBF | Visalys Core(SecondaryPredicate) | K143104 | EBF | KettenbachGmbH & Co. KG |
| Multilink Automix(PrimaryPredicate) | K123397 | EBF | Ivoclar Vivadent | |||
| Visalys Try InPaste | Try In Paste | EBF | RelyX™ Try-InPaste | K002452 | EMA | 3M Espe |
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Image /page/5/Picture/0 description: The image is a logo for KETTENBACH. The logo is set against a blue square background. The logo consists of seven white circles arranged in a triangular shape, with six circles forming the base and one circle at the apex. Below the circles, the word "KETTENBACH" is written in a bold, sans-serif font. Below the company name is the slogan "Simply intelligent".
D. Device Description:
Visalys® CemCore is a dual-curing composite containing fluoride for adhesive cementation of indirect restorations and root posts and can be used to fabricate radiopaque core build-ups and abutment fillings. Due to the Active-Connect-Technology (ACT) Visalys® CemCore includes an additional initiator system for the optimization of the adhesive bond. BPA or BPA precursors are not used in the manufacturing process of this device.
Visalys® CemCore shall only be used in combination with self-etching Visalys® Tooth Primer. Visalys® Restorative Primer is recommended as the primer for the restoration surfaces. Visalys® CemCore is easy to use and has high adhesive strength and good flowability with stable consistency.
Visalys® CemCore is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent.
The paste should be mixed and dispensed directly from a double syringe with the corresponding mixing tips blue (MLø 3.2 mm).
Visalys® CemCore Try in Paste serves to simulate the shade effect of the selected Visalys® CemCore shade on ceramic restorations and for covering the cement joint to reduce a layer of inhibition. The water-soluble paste corresponds in shade and translucence with the completely cured Visalys® CemCore.
Visalys® CemCore Try In Paste is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent.
The paste is dispensed from a syringe and syringe tip.
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Image /page/6/Picture/0 description: The image is a logo for Kettenbach, a company that uses the tagline "Simply intelligent". The logo is set against a blue background and features a geometric design of six white circles arranged in a triangular shape. The company name "KETTENBACH" is printed in bold, sans-serif font below the geometric design. To the right of the geometric design is the registered trademark symbol.
E. Indications for Use:
Visalys® CemCore is a dual-curing, adhesive cementation and core build-up composite, which is intended to be used for:
- Permanent cementation of a)
- · crowns, bridges, inlays, veneers and adhesive bridges made of metal, ceramic, composite, hybrid and oxide ceramics
- root posts and indirect core build-ups
- b) Composite for
- adhesive core build-ups
Visalys® CemCore Try In Paste water-soluble polyethylene glycol paste for shade matching
- To check the shade selected prior to permanent cementation with Visalys® CemCore.
- · For covering the cement joint to reduce a layer of inhibition.
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Image /page/7/Picture/0 description: The image contains the logo for Kettenbach. The logo features a blue square with six white circles arranged in a pyramid shape at the top. Below the circles, the word "KETTENBACH" is written in a bold, sans-serif font, and below that, the phrase "Simply intelligent" is written in a smaller, sans-serif font.
| F. Table 1: Comparison of technological characteristic with the predicate devices |
|---|
| ------------------------------------------------------------------------------------ |
| F. Table 1: Comparison of technological characteristic with the predicate devices | ||||
|---|---|---|---|---|
| Predicate Devices | Substantial Equivalent Device | Conclusion | ||
| Product | Visalys® Core (SecondaryPredicate) | Multilink® Automix (Primarypredicate) | Visalys® CemCore | |
| Manufacturer | Kettenbach | Ivoclar Vivadent | Kettenbach GmbH & Co. KG | |
| Cure type | Dual cure | Dual cure | Dual cure | |
| ProductDescription | Visalys Core is a dual-curing,fluoride-containing compositeused for the fabrication ofradiopaque core build-ups andcore fillings. | Multilink® Automix is a self-curing luting composite withlight-curing option for theadhesive luting of indirectrestorations made of metal,metal-ceramic,all-ceramic and composite. | Visalys® CemCore is a dual-curing adhesive containingfluoride for adhesivecementation of indirectrestorations and root posts.Moreover, Visalys® CemCorecan be used to fabricateradiopaque core build-upsand abutment fillings. | Visalys®CemCore issimilar toMultilink® Automix(PrimaryPredicate).Additionally,Visalys®CemCore couldalso be used foradhesive corebuild-ups. |
| Indication | - Different types of core build-ups- Luting of root posts | Multilink Automix andMultilink Primer are used forthe permanent cementationof indirect restorations wherea strong bond is desired:- Inlays, onlays, crowns,bridges and root posts madeof- metal and metal-ceramics- all-ceramics, in particularopaque zirconium oxideceramics- composites and fibre-reinforced composites | Permanent cementation of:- crowns, bridges, inlays,onlays, veneers andadhesive bridges made ofmetal, ceramic, composite,hybrid and oxide ceramics.- root posts and indirect corebuild-upsComposite for:- adhesive core build-ups | Visalys®CemCore issimilar toMultilink® Automix(PrimaryPredicate).Visalys®CemCore couldalso be used foradhesive corebuild-ups as wellas VisalysCore(SecondaryPredicate) |
| Predicate Devices | Substantial EquivalentDevice | Conclusion | ||
| Product | Visalys® Core (SecondaryPredicate) | Multilink® Automix (Primarypredicate) | Visalys® CemCore | |
| Manufacturer | Kettenbach | Ivoclar Vivadent | Kettenbach GmbH & Co. KG | |
| Cure type | Dual cure | Dual cure | Dual cure | |
| Storagetemperature | 4-24 °C / 40-75 °F | 2-28°C | 2-8 °C/36-46 °F | A storage in afridge is forVisalys®CemCorerecommended |
| Available Shades | Dentin, White, Blue | ShadesMultilink Automix is availablein four shades with differentdegrees oftranslucency:– transparent (hightranslucency)– yellow (high translucency)– opaque (low translucency)– white (mediumtranslucency) | Shades: Universal(A2/A3), Dark (A4), Opaque,Bleach und Translucent. | Similar toMultilink® Automix(PrimaryPredicate),Visalys®CemCore usesthe same colorrange, anadditional colorDark (A4) wasincluded |
| Application system | 1:1 cartridge1:1 syringe | 1:1 syringe | 1:1 syringe | Identical toMultilink® Automix(PrimaryPredicate) andVisalys® Core(SecondaryPredicate). Alluses the identicalsyringe system |
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Image /page/8/Picture/0 description: The image shows the logo for Kettenbach. The logo features a blue square with six white circles arranged in a triangular pattern. Below the square, the word "KETTENBACH" is written in a bold, sans-serif font. Underneath the company name is the tagline "Simply intelligent".
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Image /page/9/Picture/0 description: The image contains a logo for KETTENBACH. The logo features a blue square with six white circles arranged in a triangular pattern at the top. Below the circles, the word "KETTENBACH" is written in white, and below that, the phrase "Simply intelligent" is written in black.
G. Table 2: Device comparison Visalys® CemCore Try In Paste
| Predicate Devices | Substantial Equivalent Device | Conclusion | |
|---|---|---|---|
| Product | RelyX™ Try-In Paste | Visalys® Try In Paste | |
| Manufacturer | 3M Espe | Kettenbach GmbH & Co. KG | |
| Product Description | RelyX™ Try-In Pastes are used to guide the dentistin the selection of the shade required for the finalcementation with 3M™ ESPE™ RelyX™ Veneercement and RelyX Utlimate adhesive resin cement.The shades of RelyX Try-In paste specificallymatch the final cured shade of RelyX Veneercement and RelyX Ultimate cement. | Visalys® CemCore Try In Paste serves to simulatethe shade effect of the selected Visalys®CemCore shade on ceramic restorations. Thewater-soluble paste corresponds in shade andtranslucence with the completely cured Visalys®CemCore. Visalys® CemCore Try In Paste isoffered in the shades Universal (A2/A3), Dark(A4), Opaque, Bleach and Translucent. Note:Only once the cementation composite Visalys®CemCore is fully polymerized and has attained itsfinal shade, the shade coordination with the try-inpaste is attained. Visalys® CemCore Try In Pasteonly corresponds with the shades of Visalys®CemCore. | Similar,Visalys®CemCore Tryin Paste andthe predicatehave the sameindication. |
| Indications | Paste for shade matching | - Paste for shade matching- For covering the cement joint to reduce a layerof inhibition | The indicationof both devicesis identical.Visalys® Try InPaste can alsobe used forcovering thecement joint toreduce a layerof inhibition |
| Storage temperature | 2-25 °C/36 – 77 °F. | 15 - 25 °C/59 -77 °F. | For Visalys®CemCore Tryin Pastestorage at roomTemperature isrecommended. |
| Application system | Syringe | Syringe | Similar |
| The results demonstrated the substantial equivalence to the predicate devices. |
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Image /page/10/Picture/0 description: The image is a logo for KETTENBACH. The logo is set on a blue background and features six white circles arranged in a triangular shape. Below the circles, the word "KETTENBACH" is written in a bold, sans-serif font. Underneath "KETTENBACH", the phrase "Simply intelligent" is written in a smaller, sans-serif font.
H. Substantial Equivalance:
Visalys® CemCore / Visalys® CemCore Try In Paste have the same indication as the above listed predicate devices (Table 1 and 2).
The technological characteristics of Visalys® CemCore / Visalys® CemCore Try In Paste are also substantially equivalent (Table 1 and 2).
l. Non-Clinical Performance Testing:
Visalys® CemCore
Biocompatibility tests have been performed to assure biological safety in accordance with the ISO 10993 family and ISO 7405. Tests in respect to cytotoxicity (ISO 10993-5), mutagenicity (OECD 487), sensitization (ISO 10993-10) and a chemical analysis (10993-18) showed, that the biocompatibility data of Visalys® CemCore is comparable to other materials on the market. Therefore no toxicological risks and resulting hazards for patients, users and third parties can be concluded.
Additionally bench testing was performed to allow an evaluation of the mechanical properties of Visalys® CemCore in comparison to Visalys® Core (K143104/Secondary Predicate) and Multilink® Automix (K123397/Primary Predicate).
| Working time | acc. to ISO 4049 / 7.6_7.7 and ASTM D 4473 |
|---|---|
| Cure point | acc. to ISO 4049 / 7.8 and ASTM D 4473 |
| Depth of cure | acc. to ISO 4049 / 7.10 |
| Film thickness | acc. to ISO 4049 / 7.5 |
| Volume shrinkage | acc. to ISO 4049 /17304 |
| Water sorption | acc. to ISO 4049 / 7.12 |
| Solubility | acc. to ISO 4049 / 7.12 |
| Radio-opacity | acc. to ISO 4049 / 7.14 |
| E-Modulus(self-cure) | acc. to ISO 4049 / 7.11 |
| Flexural strength(self-cure) | acc. to ISO 4049 / 7.11 |
| Compressive strength (self-cure) | acc. to ISO 9917-1, Annex D |
| Diametral tensile strength(light-cure) | acc. to ADA Specification No. 27 section 4.3.7 |
| Shade consistency | Reproduction of color shades/ANSI ADA Spec.80 |
| Color stability | acc. to ISO 4049, section 7.13 andISO 7491/ANSI ADA Spec. 80 acc. to ISO 7491,section 3.2.3 |
| Visual comparison VisalysCemCore / VisalysCemCore Try In Paste | Color comparison according to ISO 7491,section 3.2.3, with three persons who perceivecolor normally |
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Image /page/11/Picture/0 description: The image contains the logo for KETTENBACH. The logo consists of a blue square with seven white circles arranged in a triangular pattern at the top. Below the circles, the word "KETTENBACH" is written in a bold, sans-serif font. Underneath the company name, the tagline "Simply intelligent" is written in a smaller, less bold font.
| Rheological properties | internal test method |
|---|---|
| Shear bond strength | ISO 20922/16506 |
| ISO 16506 (Chapter A 2.2.5). |
Visalys® CemCore Try In Paste
Biocompatibility tests have been performed to assure biological safety in accordance with the ISO 10993 family and ISO 7405. Tests in respect to cytotoxicity (ISO 10993-5) and a chemical analysis (10993-18) showed, that the biocompatibility data of Visalys® CemCore Try In Paste is comparable to other materials on the market. Therefore no toxicological risks and resulting hazards for patients, users and third parties can be concluded.
Additionally bench testing was performed to allow an evaluation of the properties of Visalys® CemCore Try In Paste
| Visual comparison Visalys® | Color comparison according to ISO 7491, section |
|---|---|
| CemCore / Visalys® CemCore TryIn Paste | 3.2.3, with three persons who perceive color |
| Layer of inhibition | normally. |
| Internal test: Comparison between the surfaces with and without Visalys®CemCore Try In Paste, with three persons which haptically evaluated the stickiness of the different surfaces after curing with or without the previous application of the Visalys®CemCore Try In Paste |
J. Clinical Performance Data
Visalys® CemCore / Visalys® CemCore Try In Paste Data from clinical studies was not provided.
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Image /page/12/Picture/0 description: The image is a logo for KETTENBACH. The logo is a blue square with six white circles arranged in a triangular shape at the top. Below the circles, the word "KETTENBACH" is written in white, sans-serif font. Underneath the company name is the slogan "Simply intelligent" in black, sans-serif font. To the right of the blue square is the registered trademark symbol.
K. Conclusion:
Based on similarities in technology and on indications for use, together with results nonclinical performance testing, we believe that Visalys® CemCore and Visalys® CemCore Try In Paste are substantially equivalent to the predicate devices.
§ 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.