(245 days)
No
The device description and performance metrics relate to the physical and chemical properties of a dental restorative material and conditioner, with no mention of AI or ML.
No.
The device is a dental restorative material used for filling cavities and building up tooth structure, not for treating diseases or conditions.
No
Explanation: The device is a restorative material used for dental fillings and core build-ups, not for diagnosing conditions.
No
The device description clearly states that DeltaFil consists of a radiopaque glass ionomer restorative material supplied in capsule form and a compatible tooth conditioner, both of which are physical materials used in dental procedures. It also mentions a dispenser, indicating a hardware component is involved in the delivery of the material.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of DeltaFil is for dental restorative procedures performed directly on the patient's teeth. This involves filling cavities and building up tooth structure.
- Device Description: The device is a dental restorative material (glass ionomer cement) and a tooth conditioner. These are materials applied to the tooth tissue within the patient's mouth.
- Anatomical Site: The anatomical site is the tooth tissue, prepared cavity, dentin, and enamel, all of which are parts of the patient's body.
- Lack of In Vitro Testing: The description of the device and its use does not involve testing of samples outside of the body (in vitro). The performance studies focus on physical properties and bond strength on tooth tissue, which is relevant to its in-vivo function.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or compatibility purposes. DeltaFil does not fit this definition. It is a therapeutic device used to restore damaged tooth structure.
N/A
Intended Use / Indications for Use
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
Product codes
EMA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth, specifically deciduous teeth and carious lesions (Class I, II, III, V)
Indicated Patient Age Range
geriatric and pediatric
Intended User / Care Setting
Dental office/clinic
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Compressive Strength (MPa) (after 24 hrs): >= 180
- Radiopacity: 200 %Al
- Acid Erosion (mm):
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/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
1
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
2
Indications for Use
510(k) Number (if known) K213201
Device Name DeltaFil, DeltaFil Conditioner
Indications for Use (Describe)
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
| 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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3
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 248 |
| 22547 Hamburg | |
| Germany | |
| 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
4
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.
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 Device
DMG DeltaFil (in capsule)
(current submission) | Predicate Device
GC Fuji IX GP (K961448) | Similarities and
Differences |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 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 |
| Attribute | Proposed Device
DMG DeltaFil (in capsule)
(current submission) | Predicate Device
GC Fuji IX GP (K961448) | Similarities and
Differences |
| 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. | 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 |
| 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 | 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 in
Mixing
Capsules? | Yes | Yes | Same |
| Capsule
Dispenser
Available? | Yes | Yes | Same |
| Powder:Liquid
Ratio | 4.96:1 | 0.40:0.11 | Similar |
| Mixing Time
(sec) | 10 | 10 | Same |
| Attribute | Proposed Device
DMG DeltaFil (in capsule)
(current submission) | Predicate Device
GC Fuji IX GP (K961448) | Similarities and
Differences |
| Working Time
(min.) at 23°C,
inclusive of
mixing time (sec) | 120 | 120 | Same |
| Net Setting Time
(max.) at 37°C,
exclusive of
mixing time (sec) | 240 | 140 | Similar |
| Compressive
Strength (MPa)
(after 24 hrs) | $\ge$ 180 | 220 | Similar; both meet
ISO 9917-1
requirement ( $\ge$ 100
MPa) |
| Radiopacity | 200 %Al | 3.7 mm | Similar; both meet
ISO 9917-1
requirement (200 %Al
= 2 mm) |
| Acid Erosion
(mm) | $\le$ 0.1 | 0.21 | Similar; DeltaFil
meets ISO 9917-1
requirement ( $\le$ 0.17
mm) |
| Shear Bond
Strength on
Dentin (MPa)
(after 24 hrs) | 4.9 ± 1.3 | 5.1 ± 2.1 | Similar for samples
prepared with
compatible
Conditioner; no
applicable ISO 9917-1
requirement |
| Shear Bond
Strength on
Enamel (MPa)
(after 24 hrs) | 13.6 ± 2.4 | 11.8 ± 7.7 | Similar for samples
prepared with
compatible
Conditioner; no
applicable ISO 9917-1
requirement |
| Acid Soluble
Lead Content
(ppm) | $\le$ 100 | unknown | Similar; DMG
material meets ISO
9917-1 requirement ( $\le$
100 ppm) |
| Opacity C0,70
(%) | 0.35 – 0.9 | unknown | Similar; DMG
material meets ISO
9917-1 requirement
(0.35 – 0.9 %) |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
| Single Use /
Reusable | Single Use | Single Use | Same |
| Sterilization /
Reprocessing
Software | Non-sterile device; no
reprocessing requirements
Device does not contain
software | Non-sterile device; no
reprocessing requirements
Device does not contain
software | Same |
| Attribute | Proposed Device
DMG DeltaFil (in capsule)
(current submission) | Predicate Device
GC Fuji IX GP (K961448) | Similarities and
Differences |
| Electrical Safety
& EMC | Not applicable | Not applicable | Same |
Substantial Equivalence Comparison Table: DeltaFil (in capsules)
5
6
7
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 |
| 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 | • Treatment of the smear layer | ||
| • Conditioning of the cavity | Dentin pretreatment prior to | ||
| filling with glass ionomer | |||
| cement | Same | ||
| Use Environment | Dental office/clinic | Dental office/clinic | Same |
| Material | |||
| Composition | 10% aqueous polyacrylic acid | ||
| Blue colorant | 20 - 30% aqueous polyacrylic | ||
| acid | |||
| Blue colorant | Same | ||
| Principle of | |||
| Operation | 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. | Ketac Conditioner improves the | ||
| adhesive bond between the tooth | |||
| tissue and the restorative cement | |||
| material by treating the smear | |||
| layer and conditioning the | |||
| prepared cavity. | Same | ||
| Technological | |||
| Characteristics | Mild PAA acid solution applied | ||
| to the prepared tooth surface | |||
| removes the smear layer, | |||
| thereby improving direct contact | |||
| between the restorative material | |||
| and intact dentin structure. | |||
| Evidence is demonstrated | |||
| through increased bond strength | |||
| for finished DeltaFil restorations | |||
| using DeltaFil Conditioner. | Mild PAA acid solution applied | ||
| to the prepared tooth surface | |||
| removes the smear layer, | |||
| thereby improving direct contact | |||
| between the restorative material | |||
| and intact dentin structure. | Same | ||
| Shear Bond Strength | |||
| on 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 and | |
| Differences | |||
| Attribute | DeltaFil Conditioner | ||
| (current submission) | 3M Espe Ketac Conditioner | ||
| (K872984) | |||
| Shear Bond Strength | |||
| on 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 blue |
| colorant. Reference | |||
| device K192273 | |||
| (Diadent DiaEtch) | |||
| used to confirm | |||
| biological safety of | |||
| methylene blue | |||
| 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 |
8
- 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
9
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.