DeltaFil (in capsule) is used for geriative filling procedures. The procedures. The product is designed for use in final restorations of Class I, II, III, and V of deciduous teeth and as a long - term restorative in non-load bearing areas of Class I and II carious lesions. It is also used as a restorative and sandwich material for heavy stress in Class I and II cavities. DeltaFil can also be used as a core build-up material.

DeltaFil Conditioner:

Treatment of the smear layer
Conditioning of the cavity

Device Description

DeltaFil consists of a radiopaque glass ionomer restorative material supplied in capsule form (DeltaFil in capsule), and a compatible tooth conditioner (DeltaFil Conditioner). DeltaFil Conditioner and DeltaFil (in capsule) are used together for the creation of permanent or temporary dental restorations as described in the device labelling. DeltaFil is available in Vita shades A1, A2, A3, A3.5, and A4.

DeltaFil (in capsule) is a two-part powder/liguid glass polyalkenoate restorative cement as defined in ISO 9917-1:2006 Dentistry - Water-Based Cements - Part 1: powder/liquid acid-base cements. The powder and liquid components are supplied in the correct mixing ratio in disposable "Applicap" capsules for use with the DMG Applicap Dispenser. DeltaFil Conditioner is a 10% aqueous polyacrylic acid solution, which is applied to the prepared tooth surface prior to placement of the mixed DeltaFil (in capsule) material. DeltaFil Conditioner improves the adhesive bond between the tooth tissue and the restorative cement material by treating the smear layer and conditioning the prepared cavity.

AI/ML Overview

This is a 510(k) premarket notification for a dental device, not an AI/ML device, so the usual criteria for AI/ML acceptance and studies are not applicable. The document discusses performance criteria for a dental cement and conditioner.

Here's an analysis based on the provided text, focusing on the nearest equivalents to your requested categories for a non-AI/ML medical device:

The device under review is DeltaFil (in capsule), a radiopaque glass ionomer restorative material, and DeltaFil Conditioner, a 10% aqueous polyacrylic acid solution. Both are used in dental filling procedures.

1. A table of acceptance criteria and the reported device performance

The document provides a comparison table against two predicate devices (GC Fuji IX GP for DeltaFil and 3M Espe Ketac Conditioner for DeltaFil Conditioner), which implicitly sets the acceptance criteria by demonstrating "substantial equivalence." The acceptance criteria are essentially defined by meeting or being similar to the performance characteristics of the legally marketed predicate devices, and in some cases, meeting ISO standards.

Acceptance Criteria and Reported Device Performance (Derived from Comparison Tables):

For DeltaFil (in capsule) vs. Predicate GC Fuji IX GP (K961448):

Attribute	Acceptance Criteria (Predicate/ISO Standard)	Reported Device Performance (DMG DeltaFil)	Result
Common Name	Restorative Dental Cement and Tooth Conditioner	Restorative Dental Cement and Tooth Conditioner	Same
Classification Name	Dental Cement	Dental Cement	Same
Device Class	II	II	Same
Regulation	21 CFR 872.3275	21 CFR 872.3275	Same
Regulation Name	Dental Cement	Dental Cement	Same
Product Code	EMA	EMA	Same
Indications for Use	Similar to Predicate (geriatric/pediatric fillings, Class I, II, III, V deciduous teeth, long-term restorative in non-load bearing Class I & II lesions, restorative/sandwich material for heavy stress in Class I & II, core build-up)	Same as Predicate	Same
Use Environment	Dental office/clinic	Dental office/clinic	Same
Material Composition	Radiopaque glass ionomer cement supplied in capsules	Radiopaque glass ionomer cement supplied in capsules	Same
Principle of Operation	Two-part powder-liquid glass ionomer polyalkenoate restorative dental cement as defined in ISO 9917-1:2007	Same, with Conditioner applied to condition tooth surface	Same
Supplied in Mixing Capsules?	Yes	Yes	Same
Capsule Dispenser Available?	Yes	Yes	Same
Powder:Liquid Ratio	0.40:0.11 (Predicate)	4.96:1	Similar (different numerical ratio but functionally equivalent for purpose)
Mixing Time (sec)	10	10	Same
Working Time (min.) at 23°C (inclusive of mixing time)	120	120	Same
Net Setting Time (max.) at 37°C (exclusive of mixing time)	140 (Predicate)	240	Similar (within acceptable range)
Compressive Strength (MPa) (after 24 hrs)	$\ge$ 100 MPa (ISO 9917-1 requirement) / 220 (Predicate)	$\ge$ 180	Similar; both meet ISO 9917-1 requirement
Radiopacity	2 mm Al (ISO 9917-1 requirement) / 3.7 mm (Predicate)	200 %Al	Similar; both meet ISO 9917-1 requirement fund.
Acid Erosion (mm)	$\le$ 0.17 mm (ISO 9917-1 requirement) / 0.21 (Predicate)	$\le$ 0.1	Similar; DeltaFil meets ISO 9917-1 requirement
Shear Bond Strength on Dentin (MPa) (after 24 hrs)	5.1 ± 2.1 (Predicate with Conditioner)	4.9 ± 1.3 (with Conditioner)	Similar (for samples prepared with compatible Conditioner)
Shear Bond Strength on Enamel (MPa) (after 24 hrs)	11.8 ± 7.7 (Predicate with Conditioner)	13.6 ± 2.4 (with Conditioner)	Similar (for samples prepared with compatible Conditioner)
Acid Soluble Lead Content (ppm)	$\le$ 100 ppm (ISO 9917-1 requirement) / unknown (Predicate)	$\le$ 100	Similar; DMG material meets ISO 9917-1 requirement
Opacity C0,70 (%)	0.35 – 0.9 % (ISO 9917-1 requirement) / unknown (Predicate)	0.35 – 0.9	Similar; DMG material meets ISO 9917-1 requirement
Biocompatibility	ISO 10993	ISO 10993	Same
Single Use / Reusable	Single Use	Single Use	Same
Sterilization / Reprocessing	Non-sterile device; no reprocessing requirements	Non-sterile device; no reprocessing requirements	Same
Software	Device does not contain software	Device does not contain software	Same
Electrical Safety & EMC	Not applicable	Not applicable	Same

For DeltaFil Conditioner vs. Predicate 3M Espe Ketac Conditioner (K872984):

Attribute	Acceptance Criteria (Predicate/Implied)	Reported Device Performance (DeltaFil Conditioner)	Result
Common Name	Tooth Conditioner	Tooth Conditioner	Same
Classification Name	Dental Cement	Dental Cement	Same
Device Class	II	II	Same
Regulation	21 CFR 872.3275	21 CFR 872.3275	Same
Regulation Name	Dental Cement	Dental Cement	Same
Product Code	EMA	EMA	Same
Indications for Use	Similar to Predicate (Dentin pretreatment prior to filling with glass ionomer cement)	Treatment of the smear layer, Conditioning of the cavity	Same
Use Environment	Dental office/clinic	Dental office/clinic	Same
Material Composition	20 - 30% aqueous polyacrylic acid, blue colorant (Predicate)	10% aqueous polyacrylic acid, Blue colorant	Similar (different concentration but functionally similar)
Principle of Operation	Improves adhesive bond between tooth tissue and restorative cement by treating smear layer and conditioning cavity	Same	Same
Technological Characteristics	Mild PAA acid solution applied to prepared tooth surface removes smear layer, improving direct contact for restorative material.	Same, with evidence shown through increased bond strength for DeltaFil	Same
Shear Bond Strength on Dentin (with Conditioner)	5.1 ± 2.1 (Predicate)	4.9 ± 1.3	Similar
Shear Bond Strength on Dentin (without Conditioner)	6.5 ± 1.5 (Predicate)	4.4 ± 3.7	Similar
Shear Bond Strength on Enamel (with Conditioner)	11.8 ± 7.7 (Predicate)	13.6 ± 2.4	Similar
Shear Bond Strength on Enamel (without Conditioner)	10.6 ± 4.5 (Predicate)	13.6 ± 6.5	Similar
Biocompatibility	ISO 10993	ISO 10993 (with reference to K192273 for methylene blue pigment)	Same (with justification for colorant)
Single Use / Reusable	Single Use	Single Use	Same
Sterilization / Reprocessing	Non-sterile device; no reprocessing requirements	Non-sterile device; no reprocessing requirements	Same
Software	Device does not contain software	Device does not contain software	Same
Electrical Safety & EMC	Not applicable	Not applicable	Same

2. Sample size used for the test set and the data provenance

The document states "Performance data demonstrated that DeltaFil (in capsule) and DeltaFil Conditioner meet all predetermined acceptance criteria contained in the product specification and are suitable for their intended use." It also mentions "Design verification and validation activities consisted of physical testing, biocompatibility evaluation, and stability (shelf life) validation."

However, specific sample sizes for each physical test (e.g., compressive strength, radiopacity, shear bond strength, acid erosion) are not detailed in this summary. The provenance of the data is not explicitly stated beyond being studies conducted to support the substantial equivalence claim for the subject device. It is generally understood that such testing is conducted by the manufacturer (DMG Chemisch-Pharmazeutische Fabrik GmbH, Germany). The studies are likely prospective tests performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as this is not an AI/ML device, and therefore no "experts" are adjudicating image interpretations or similar for ground truth. The "ground truth" for the performance tests comes from objective physical and chemical measurements (e.g., MPa for strength, mm for erosion, %Al for radiopacity) against established ISO standards and comparisons to predicate device data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no human adjudication of results in the way it would be for an AI/ML diagnostic device interpreting images. Physical and chemical tests typically involve standardized protocols and measurements.

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 device is a dental material, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm. The performance evaluation is inherently for the materials themselves.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the DeltaFil and DeltaFil Conditioner, the "ground truth" is established through:

International Standards: Primarily ISO 9917-1:2007 (Dentistry - Water-Based Cements - Part 1: powder/liquid acid-base cements) for physical and chemical properties like compressive strength, radiopacity, acid erosion, and acid soluble lead content.
Predicate Device Data: Performance characteristics of legally marketed devices (GC Fuji IX GP and 3M Espe Ketac Conditioner) serve as a benchmark for comparison.
Biocompatibility Standards: ISO 10993 for biological evaluation of medical devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set. The regulatory path is based on demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards through physical and biocompatibility testing.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DMG Chemisch-Pharmazeutische Fabrik GmbH Pamela Papineau Consultant Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave Ayer, Massachusetts 01432

Re: K213201

Trade/Device Name: DeltaFil, DeltaFil Conditioner Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: April 21, 2022 Received: April 27, 2022

Dear Pamela 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. 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 mediation-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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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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Indications for Use

510(k) Number (if known) K213201

Device Name DeltaFil, DeltaFil Conditioner

Indications for Use (Describe)

DeltaFil Conditioner:

Treatment of the smear layer
· Conditioning of the cavity

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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K213201

DeltaFil 510(k) Summary (revised)

General Information
Preparation date:	31 May 2022
Owner's Name:	DMG Chemisch-Pharmazeutische Fabrik GmbH(FDA Registration 8044164)
Address:	Elbgaustrasse 24822547 HamburgGermany
Telephone Number:	011-49-40-84006-0
Fax Number:	011-49-40-84006-222
Contact Person:	Stephan Schaefer
Subject Device Name:	DeltaFil
Trade Name:	DeltaFil, DeltaFil Conditioner
Common/Usual Name:	Dental Cement and Conditioner
Product Codes:	EMA
Regulations:	21 CFR 872.3275 (Dental Cement)
Device Classification:	II
Predicate Devices:
Trade Name:	Fuji IX GP (GC America, Inc.)
Common/Usual Name:	Dental Cement
Product Code:	EMA
Regulation:	21 CFR 872.3275 (Dental Cement)
Device Classification:	II
Premarket Notification:	K961448
Trade Name:	Ketac Conditioner (3M ESPE GmbH)
Common/Usual Name:	Tooth Conditioner
Product Code:	EMA
Regulation:	21 CFR 872.3275 (Dental Cement)
Device Classification:	II
Premarket Notification:	K872984
Reference Device:
Trade Name:	DiaEtch (Diadent Group International)
Common/Usual Name:	Resin Tooth Bonding Agent
Product Code:	KLE
Regulation:	21 CFR 872.3200 (Resin Tooth Bonding Agent)
Device Classification:	II
Premarket Notification:	K192273
Device Description

DeltaFil consists of a radiopaque glass ionomer restorative material supplied in capsule form (DeltaFil in capsule), and a compatible tooth conditioner (DeltaFil Conditioner). DeltaFil Conditioner

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and DeltaFil (in capsule) are used together for the creation of permanent or temporary dental restorations as described in the device labelling. DeltaFil is available in Vita shades A1, A2, A3, A3.5, and A4.

Indications for Use

DeltaFil (in capsule) is used for geriatric and pediatric restorative filling procedures. The product is designed for use in final restorations of Class I, II, III, and V of deciduous teeth and as a long - term restorative in non-load bearing areas of Class I and II carious lesions. It is also used as a restorative and sandwich material for heavy stress in Class I and II cavities. DeltaFil can also be used as a core build-up material.

DeltaFil Conditioner:

Treatment of the smear layer ●
. Conditioning of the cavity

Substantial Equivalence / Comparison of Technical Characteristics with the Predicate Device The predicate devices are the GC Fuji IX GP cleared in K961448, and the 3M Espe Ketac Conditioner cleared in K872984. A summary comparison of the subject and predicate device systems is provided in the substantial equivalence table below.

Attribute	Proposed DeviceDMG DeltaFil (in capsule)(current submission)	Predicate DeviceGC Fuji IX GP (K961448)	Similarities andDifferences
Common Name	Restorative Dental Cementand Tooth Conditioner	Restorative Dental Cement andTooth Conditioner	Same
ClassificationName	Dental Cement	Dental Cement	Same
Device Class	II	II	Same
Regulation	21 CFR 872.3275	21 CFR 872.3275	Same
RegulationName	Dental Cement	Dental Cement	Same
Product Code	EMA	EMA	Same
Attribute	Proposed DeviceDMG DeltaFil (in capsule)(current submission)	Predicate DeviceGC Fuji IX GP (K961448)	Similarities andDifferences
Indicationsfor Use	DeltaFil (in capsule) is used for geriatric and pediatric restorative filling procedures. The product is designed for use in final restorations of Class I, II, III, and V of deciduous teeth and as a long - term restorative in non-load bearing areas of Class I and II carious lesions. It is also used as a restorative and sandwich material for heavy stress in Class I and II cavities. DeltaFil can also be used as a core build-up material.	GC Fuji IX GP is used for geriatric and pediatric restorative filling procedures. The product is designed for use in final restorations of Class I, II, III, and V of deciduous teeth and as a long - term restorative in non-load bearing areas of Class I and II carious lesions. It is also used as an immediate restorative and sandwich material for heavy stress in Class I and II cavities. FUJI IX GP can also be used as a core build-up material.	Same
UseEnvironment	Dental office/clinic	Dental office/clinic	Same
MaterialComposition	Radiopaque glass ionomer cement supplied in capsules	Radiopaque glass ionomer cement supplied in capsules	Same
Principle ofOperation	DeltaFil (in capsule) is a two-part powder-liquid glass ionomer polyalkenoate restorative dental cement as defined in ISO 9917-1:2007 Dentistry – Water-Based Cements – Part 1: powder/liquid acid-base cements. DeltaFil Conditioner is applied to condition the prepared tooth surface prior to placement of the mixed DeltaFil Capsule material.	GC Fuji IX GP is a two-part powder-liquid glass ionomer polyalkenoate restorative dental cement as defined in ISO 9917-1:2007 Dentistry – Water-Based Cements – Part 1: powder/liquid acid-base cements.	Same
Supplied inMixingCapsules?	Yes	Yes	Same
CapsuleDispenserAvailable?	Yes	Yes	Same
Powder:LiquidRatio	4.96:1	0.40:0.11	Similar
Mixing Time(sec)	10	10	Same
Attribute	Proposed DeviceDMG DeltaFil (in capsule)(current submission)	Predicate DeviceGC Fuji IX GP (K961448)	Similarities andDifferences
Working Time(min.) at 23°C,inclusive ofmixing time (sec)	120	120	Same
Net Setting Time(max.) at 37°C,exclusive ofmixing time (sec)	240	140	Similar
CompressiveStrength (MPa)(after 24 hrs)	$\ge$ 180	220	Similar; both meetISO 9917-1requirement ( $\ge$ 100MPa)
Radiopacity	200 %Al	3.7 mm	Similar; both meetISO 9917-1requirement (200 %Al= 2 mm)
Acid Erosion(mm)	$\le$ 0.1	0.21	Similar; DeltaFilmeets ISO 9917-1requirement ( $\le$ 0.17mm)
Shear BondStrength onDentin (MPa)(after 24 hrs)	4.9 ± 1.3	5.1 ± 2.1	Similar for samplesprepared withcompatibleConditioner; noapplicable ISO 9917-1requirement
Shear BondStrength onEnamel (MPa)(after 24 hrs)	13.6 ± 2.4	11.8 ± 7.7	Similar for samplesprepared withcompatibleConditioner; noapplicable ISO 9917-1requirement
Acid SolubleLead Content(ppm)	$\le$ 100	unknown	Similar; DMGmaterial meets ISO9917-1 requirement ( $\le$100 ppm)
Opacity C0,70(%)	0.35 – 0.9	unknown	Similar; DMGmaterial meets ISO9917-1 requirement(0.35 – 0.9 %)
Biocompatibility	ISO 10993	ISO 10993	Same
Single Use /Reusable	Single Use	Single Use	Same
Sterilization /ReprocessingSoftware	Non-sterile device; noreprocessing requirementsDevice does not containsoftware	Non-sterile device; noreprocessing requirementsDevice does not containsoftware	Same
Attribute	Proposed DeviceDMG DeltaFil (in capsule)(current submission)	Predicate DeviceGC Fuji IX GP (K961448)	Similarities andDifferences
Electrical Safety& EMC	Not applicable	Not applicable	Same

Substantial Equivalence Comparison Table: DeltaFil (in capsules)

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Substantial Equivalence Comparison Table: DeltaFil Conditioner

	Proposed Device	Predicate Device	Similarities and
Attribute	DeltaFil Conditioner(current submission)	3M Espe Ketac Conditioner(K872984)	Differences
Common Name	Tooth Conditioner	Tooth Conditioner	Same
ClassificationName	Dental Cement	Dental Cement	Same
Device Class	II	II	Same
Regulation	21 CFR 872.3275	21 CFR 872.3275	Same
RegulationName	Dental Cement	Dental Cement	Same
Product Code	EMA	EMA	Same
Indicationsfor Use	• Treatment of the smear layer• Conditioning of the cavity	Dentin pretreatment prior tofilling with glass ionomercement	Same
Use Environment	Dental office/clinic	Dental office/clinic	Same
MaterialComposition	10% aqueous polyacrylic acidBlue colorant	20 - 30% aqueous polyacrylicacidBlue colorant	Same
Principle ofOperation	DeltaFil Conditioner improvesthe adhesive bond between thetooth tissue and the restorativecement material by treating thesmear layer and conditioning theprepared cavity.	Ketac Conditioner improves theadhesive bond between the toothtissue and the restorative cementmaterial by treating the smearlayer and conditioning theprepared cavity.	Same
TechnologicalCharacteristics	Mild PAA acid solution appliedto the prepared tooth surfaceremoves the smear layer,thereby improving direct contactbetween the restorative materialand intact dentin structure.Evidence is demonstratedthrough increased bond strengthfor finished DeltaFil restorationsusing DeltaFil Conditioner.	Mild PAA acid solution appliedto the prepared tooth surfaceremoves the smear layer,thereby improving direct contactbetween the restorative materialand intact dentin structure.	Same
Shear Bond Strengthon Dentin*	$4.9 \pm 1.3$ (with Conditioner)$4.4\pm 3.7$ (without Conditioner)	$5.1 \pm 2.1$ (with Conditioner*)$6.5 \pm 1.5$ (without Conditioner)	Similar
	Proposed Device	Predicate Device	Similarities andDifferences
Attribute	DeltaFil Conditioner(current submission)	3M Espe Ketac Conditioner(K872984)
Shear Bond Strengthon Enamel*	$13.6 \pm 2.4$ (with Conditioner)$13.6 \pm 6.5$ (without Conditioner)	$11.8 \pm 7.7$ (with Conditioner*)$10.6 \pm 4.5$ (without Conditioner)	Similar
Biocompatibility	ISO 10993	ISO 10993	Same except for bluecolorant. Referencedevice K192273(Diadent DiaEtch)used to confirmbiological safety ofmethylene bluecolorant.
Single Use /Reusable	Single Use	Single Use	Same
Sterilization /Reprocessing	Non-sterile device; noreprocessing requirements	Non-sterile device; noreprocessing requirements	Same
Software	Device does not containsoftware	Device does not containsoftware	Same
Electrical Safety &EMC	Not applicable	Not applicable	Same

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Predicate SBS data for GC Fuji IX GP with and without the compatible GC Cavity Conditioner

Non-clinical Performance Testing

Performance data demonstrated that DeltaFil (in capsule) and DeltaFil Conditioner meet all predetermined acceptance criteria contained in the product specification and are suitable for their intended use. The risks associated with the use of the new devices were found acceptable when evaluated in accordance with ISO 14971. Risks and benefits associated with the proposed and the predicate device are the same. Design verification and validation activities consisted of physical testing, biocompatibility evaluation, and stability (shelf life) validation.

Comparison of Technological Characteristics with the Predicate Devices

The general material type, intended use, and performance specifications of DeltaFil (in capsule) and DeltaFil Conditioner are substantially equivalent to the predicate devices, GC Fuji IX GP and 3M Espe Ketac Conditioner. DeltaFil (in capsule) and GC Fuji IX GP are two-part powder-liquid glass ionomer polyalkenoate restorative dental cement as defined in ISO 9917-1:2007 Dentistry - Water-Based Cements – Part 1: powder/liquid acid-base cements. Both DeltaFil (in capsule) and GC Fuji IX GP are supplied in capsules that are briefly mixed by the user in a standard dental capsule mixer prior to dispensing.

DeltaFil Conditioner and 3M Espe Ketac Conditioner are both mild, blue-tinted aqueous solutions of polyacrylic acid intended to enhance the bond between the glass ionomer restorative cement and the tooth surface by treating the smear layer to condition the cavity. DeltaFil Conditioner is intended for use prior to the application of DeltaFil (in capsule). The Diadent DiaEtch cleared in K192273 is cited

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as a reference device to confirm biological safety for methlylene blue pigment used to enhance the visibility of dental cavity pretreatments.

Conclusion

The DMG Chemisch-Pharmazeutische Fabrik GmbH DeltaFil (in capsule) and DeltaFil Conditioner meet all pre-determined acceptance criteria of the testing performed to confirm substantial equivalence to the predicate devices.

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.