(162 days)
Not Found
No
The 510(k) summary describes a traditional dental restorative material (glass ionomer) and its physical and chemical properties. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is a restorative material used for dental fillings and core build-ups, which are used to repair or replace tooth structure. While it contributes to oral health, its primary function is not to treat a disease or condition in a therapeutic sense, but rather to restore function and structure.
No
The device description and intended use indicate that Ketac Universal Aplicap is a restorative material used for fillings and core build-up. It is a therapeutic device, not a diagnostic one. Diagnostic devices are used to identify or detect a disease or condition.
No
The device description clearly states it is a "radiopaque glass ionomer restorative delivered in capsules," indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health.
- This device is a dental restorative material. It is used to fill cavities and build up tooth structure directly in the patient's mouth.
The provided information clearly describes a material used for dental procedures, not for testing biological samples.
N/A
Intended Use / Indications for Use
- Linings for single-surface and multiple-surface composite fillings
- Core build-up prior to crown placement
- Primary tooth fillings
- Stress bearing Class I restorations with at least one additional support outside of the filling area
- Stress bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area
- Cervical fillings, if aesthetics is not the prime consideration
- Single-surface and multiple-surface temporary fillings
- Fissure sealing
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Ketac Universal Aplicap is a radiopaque glass ionomer restorative delivered in capsules used for bulk fillings. It can be applied without lining; releases fluoride ions and is available in various shades corresponding to the Vita™ Classical color system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The indication for use in primary tooth fillings emphasizes that the material is suitable for use for use in children.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro testing was conducted to examine consistency, maximum solubility, dimensional change, working and setting time, bonding strength, fluoride release, compressive strength, 3-point flexural strength, and surface hardness comparing the performance of Ketac Universal Aplicap to Equia.
Key results:
- In case of dimensional change, 3-point flexural strength and bonding strength to enamel the values for both devices are nearly identical.
- The adhesion of Equia on dentin is higher compared to Ketac Universal Aplicap. However, a clinical literature review showed that a performance in the range of Ketac Universal Aplicap are clinically sufficient.
- With respect to fluoride release Equia shows a higher rate in the first month and a comparable rate to Ketac Universal Aplicap thereafter.
- With respect to consistency, working time and setting time these properties show slightly differences depending on the preferences of the dentist.
- Both materials have a solubility on a low level that does not effect biocompatibility.
- The compressive strength (according in-house method) and the surface hardness of Ketac Universal Aplicap exhibited higher values than the predicate device Equia which should lead to higher longevity of the restoration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Equia (K091106)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
3M Deutschland GmbH Ruediger Franke ESPE Platz Seefeld, Bavaria 82229 GERMANY
Re: K153174
Trade/Device Name: Ketac Universal Aplicap Regulation Number: 21 CFR 872.3275 Regulation Name: Dental cement Regulatory Class: Class II Product Code: EMA Dated: March 14, 2016 Received: March 16, 2016
Dear Mr. Ruediger Franke:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
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 Ketac Universal Aplicap
Indications for Use (Describe)
-
Linings for single-surface and multiple-surface composite fillings
-
Core build-up prior to crown placement
-
Primary tooth fillings
-
Stress bearing Class I restorations with at least one additional support outside of the filling area
-
Stress bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area
-
Cervical fillings, if aesthetics is not the prime consideration
-
Single-surface and multiple-surface temporary fillings
-
Fissure sealing
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (8/14)
Page 1 of 1
3
C. M
3M Deutschland GmbH
Carl-Schurz-Straße 1 41453 Neuss Germany
Postal Address: ESPE Platz 82229 Seefeld Germany
電+49 (0)8152 700-0 룡 +49 (0)8152 700-1366 Internet: www.3MESPE.de E-Mail: info3MESPE@3M.com WEEE-Reg.-Nr. DE 36963167 VAT-ID: DE 120679179
510(k) Summary
| 510(k) submitter: | 3M Deutschland GmbH
ESPE Platz
82229 Seefeld
Germany
Establishment Registration Number: 961138 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruediger Franke
Regulatory Affairs Specialist
Phone: +49-8152-700 1802
Fax: +49-8152-700 1869
e-mail: ruediger.franke@3M.com |
| Date: | March 14, 2016 |
| Trade Name: | Ketac Universal Aplicap |
| Common Name: | Glass ionomer restorative material |
| Classification Name: | Dental cement
(21 CFR 872.3275, product code EMA) |
| Device Class: | Class II |
| Predicate Devices | Equia (K091106) |
Description of Device
Ketac Universal Aplicap is a radiopaque glass ionomer restorative delivered in capsules used for bulk fillings. It can be applied without lining; releases fluoride ions and is available in various shades corresponding to the Vita™ Classical color system.
Applicable Standards for Product Tests
- ISO 9917-1: Dentistry-- Water-based cements Part 1: Powder/liquid acid-base . cements
- 1SO 29022: Dentistry Adhesive Notched Edge Sheer Bond Strength Test .
Image /page/3/Picture/13 description: The image shows a logo with three concentric circles and the text "Deutsche" and "Center". To the right of the logo, the text "Page 4 of 28" is visible. The logo appears to be a certification mark or symbol, possibly related to German standards or quality assurance.
4
Indications for Use for Ketac Universal Aplicap
- Linings for single- and multiple-surface composite fillings
- · Core build-up prior to crown placement
- · Primary tooth fillings
- Stress bearing Class I restorations with at least one additional support outside of the filling area
- · Stress bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area
- · Cervical fillings, if aesthetics is not the prime consideration
- · Single- and multiple-surface temporary fillings
- Fissure sealing .
Comparison
| Ketac Universal Aplicap | Equia
(Predicate Device,
(K091106, by GC) | Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stress bearing Class I
restorations with at least
one additional support
outside of the filling area | Class I restorations | More restrictive and conservative
Class I indication for Ketac Universal
Aplicap despite comparable
mechanical properties |
| - | Non-stress bearing
Class II restorations | Despite comparable mechanical
properties this indication is not
claimed by 3M Deutschland GmbH |
| Stress bearing Class II
restorations when the
isthmus is less than half of
the intercuspal distance and
with at least one additional
support outside of the filling
area | Stress bearing Class
II restorations when
the isthmus is less
than half of
intercuspal distance | More restrictive and conservative
Class II indication for Ketac
Universal Aplicap despite
comparable mechanical properties |
| Single- and multiple-surface
temporary fillings | Intermediate
restorative | Same indication but different
wording. |
| Cervical fillings, if aesthetics
is not the prime
consideration | Class V and root
surface restorations | Same indication but different
wording. |
| Core build up prior to crown
placement | Core build-up | Same indication but different
wording. |
| Linings for single- and
multiple-surface composite
fillings | - | Indication is not separately claimed
by GC. The indication linings can be
viewed as a small Class I/Class II
restorations with reduced
mechanical performance
requirements. |
5
| Ketac Universal Aplicap | Equia
(Predicate Device,
(K091106, by GC) | Comparison |
|-------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary tooth fillings | - | Indication is not separately claimed
by GC. The indication for use in
primary tooth fillings emphasizes
that the material is suitable for use
for use in children. |
| Fissure sealing | - | Indication is not separately claimed
by GC. The indication fissure sealing
is comparable with a small Class I
indication. |
Table Comparison of indications
Despite comparable mechanical properties between the two products 3M Deutschland GmbH uses a more restrictive and conservative range for Ketac Universal Aplicap for stress bearing Class I and Class II indications in comparison to GC America for Equia. The restriction to recommend additional support from outside the filling area will give additional support to the filling and therefore reduce the stress.
The indications for use in temporary filling, Class V restorations and core build-ups are equivalent for Ketac Universal Aplicap and the predicate device but with a slightly different wording.
Additional comments to Indication subset not claimed by GC
- Linings for single- and multiple-surface composite fillings .
- . Fissure sealing
- . Primary tooth fillings
All three indications are subsets of the listed indications in table Comparison of indications. Linings for single-surface and multiple-surface composite fillings are only a thin layer under a protective composite filling material. Therefore, linings can be considered as small Class I/ Class II restorations with reduced mechanical performance requirements.
The indication for use in fissure sealing is comparable with a small Class I indication. The indication for use in primary tooth fillings emphasizes that the material is suitable for use in children.
These subset indications claimed for Ketac Universal Aplicap are not claimed by GC but don't influence the safety and efficacy of the device Ketac Universal Aplicap because the mechanical requirements for the material are fully covered by the other indications listed in the table Comparison of indications.
6
In summary, it can be stated that all listed indications of Ketac Universal Aplicap are equivalent to the predicate device Equia with no new or increased indication.
| | Ketac Universal
Aplicap | Equia
(Predicate Device,
(K091106, by GC) | Comparison |
|-------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Essential
Ingredients | Polyacrylic Acid,
Oxide Glass
Chemicals, Water,
and Tartaric Acid | Polyacrylic Acid,
Oxide Glass
Chemicals, Water,
and Tartaric Acid | equivalent |
| Powder/liquid
compounds
delivered in
capsules | X | X | equal |
| Glass
polyalkenoate
cement
according ISO
9917-1: 2007 | X | X | equal |
| Use of
conditioner | No | X | It has been demonstrated that a
conditioner does not increase the
bonding strength of Ketac
Universal Aplicap |
| Use of coat | Possible according
IFU, but not
mandatory | X | It has been demonstrated that a
coat does not increase the
surface hardness of Ketac
Universal Aplicap. |
| Properties | Ketac
Universal
Aplicap | Equia
(Predicate Device,
(K091106, by GC) | Comparison |
| Consistency /mm | 14 | 16 | There is no guidance or standard
available to refer to.
The consistency of Ketac Universal
Aplicap (14 mm) and Equia (16 mm)
is comparable. |
| Maximum solubility /% | 0.11 | 0.06 | The solubility as single property is not
addressed by a standard or guidance.
The solubility of Equia is lower than
that of Ketac Universal Aplicap but
both materials have a solubility on a
low level that does not effect
biocompatibility or mechanical
properties. Moreover, Ketac Universal
Aplicap meets the ISO 9917-1:2007
requirement with no acid soluble
arsenic or lead content (0.00 mg/kg). |
| Dimensional change,
24 hours /% | 0.24 | 0.16 | The dimensional change as single
property is not addressed by a
standard or guidance. |
| Dimensional change,
72 hours /% | 0.18 | 0.12 | The change of length of Ketac
Universal Aplicap is low and
comparable to Equia at 24 hours and
at 72 hours. Based on the accuracy of
the test method it is concluded that
the changes of lengths of Ketac
Universal Aplicap are comparable to
those of Equia. |
| Working time /min:sec
(in-house method) | 1:48 | 1:12 | The working time as single property is
not addressed by a standard or
guidance.
The working time according the in-
house method of Ketac Universal is
higher than for Equia. It generally
depends on the preference of the
dentist. A longer working time
provides the dentist with more time to
handle the material. |
| Setting time /min:sec
(in-house method) | 2:42 | 2:12 | The setting times for Ketac universal
Aplicap and Equia were evaluated |
| Setting time /min:sec
(ISO 9917:2007) | 2:30 | 1:43 | according ISO 9917:2007. Both are
within the limit of 1.5 - 6.0 minutes.
The setting times according to the in-
house method are for Ketac Universal
Aplicap and Equia only slightly
different to the times stated in the
instruction for use. Ketac Universal
Aplicap has longer setting time than
Equia. Also for this material property
the ideal working and setting times
depend on the preferences of
dentists. |
| Properties | Ketac
Universal
Aplicap | Equia
(Predicate Device,
(K091106, by GC) | Comparison |
| Bonding strength,
enamel /MPa | 5.7 | 5.0 | Equia and Ketac Universal Aplicap
have comparable adhesion values on
human enamel. |
| Bonding strength,
dentin /MPa | 5.1 | 10.0 | The adhesion of Equia on dentin is
higher compared to Ketac Universal
Aplicap. The review of clinical
literature was presented in the 510(k),
The literature showed that bonding
strength of Ketac Universal Aplicap is
sufficient for use. Therefore, this
difference has no significant impact. |
| Fluoride release, 1
day /ppm | 4.0 | 5.9 | The fluoride release rate as single
property is not addressed by a
standard or guidance. |
| Fluoride release, 1
week /ppm | 8.7 | 13.5 | Ketac Universal Aplicap and Equia
release fluoride ions over a time
period of at least 12 months. The |
| Fluoride release, 2
weeks /ppm | 11.4 | - | |
| Fluoride release, 1
month /ppm | 14.8 | 21.5 | release of Equia is higher than Ketac
Universal Aplicap during the first
month. Afterwards the release rates
are comparable. |
| Fluoride release, 3
months /ppm | 22.4 | 30.4 | |
| Fluoride release, 6
months /ppm | 29.2 | 38.6 | |
| Fluoride release, 9
months /ppm | 35.1 | 44.6 | |
| Fluoride release, 12
months /ppm | 39.8 | 49.4 | |
| Compressive Strength
(ISO 9917-1) /MPa | 188 | 200 | Ketac Universal Aplicap and Equia
show comparable values according to
the ISO method and both are above
the limit of 100 MPa for glass
polyalkenoate cements. |
| Compressive Strength
(In-house method)
/MPa | 251.4 | 206.7 | Ketac Universal Aplicap shows a
higher compressive strength than
Equia according the modified method
of ISO 9917-1 which should be
beneficial for the longevity. |
| 3-Point Flexural
Strength /MPa | 50.2 | 46.4 | The flexural strength as single
property is not addressed by a
standard or guidance for water based
glass ionomer cements.
Ketac Universal Aplicap and Equia
have similar 3-point flexural strengths. |
| Surface Hardness 24
hours /MPa | 667.0 | 498.7 | The surface hardness as single
property is not addressed by a
standard or guidance.
Ketac Universal Aplicap shows a
higher surface hardness than Equia
which should be beneficial for the
longevity. |
Table Comparison of essential ingredients and technology
Ketac Universal Aplicap and Equia are glass polyalkenoate cements compliant with ISO 9917-1: 2007 delivered in capsules. The essential ingredients of both products are polyacrylic acid, oxide glass chemicals, water, and tartaric acid. The main difference in the application of Ketac Universal Aplicap to the predicate device Equia is that for Ketac Universal Aplicap neither a coat nor the use of conditioner is required. It has been shown that the use of a coat does not increase the surface hardness of Ketac Universal Aplicap. Further it has been demonstrated that a conditioner does not increase the bonding strength. In Summary, both products are glass polyalkenoate cements with similar composition and technology. Additional coating or conditioning steps did not lead to superior properties (surface hardness, adhesion) for Ketac Universal Aplicap.
In vitro testing was conducted to examine consistency, maximum solubility, dimensional change, working and setting time, bonding strength, fluoride release, compressive strength, 3-point flexural strength, and surface hardness comparing the performance of Ketac Universal Aplicap to Equia.
7
8
Table Comparison of physical and mechanical properties
:
:
9
In case of dimensional change, 3-point flexural strength and bonding strength to enamel the values for both devices are nearly identical. The adhesion of Equia on dentin is higher compared to Ketac Universal Aplicap. However, a clinical literature review showed that a performance in the range of Ketac Universal Aplicap are clinically sufficient. With respect to fluoride release Equia shows a higher rate in the first month and a comparable rate to Ketac Universal Aplicap thereafter. With respect to consistency, working time and setting time these properties show slightly differences depending on the preferences of the dentist. Both materials have a solubility on a low level that does not effect biocompatibility. The compressive strength (according in-house method) and the surface hardness of Ketac Universal Aplicap exhibited higher values than the predicate device Equia which should lead to higher longevity of the restoration.
Biocompatibility
The biocompatibility assessment for this product was conducted in accordance with the following quidance:
-
Testing guidelines outlined in the FDA General Program Memorandum G95. 2) ISO 10993-1:2009(E) Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process; in addition, relevant detailed guidance in ISO Standards 10993-3:2014 (Tests for genotoxicity, carcinogenicity and reproductive toxicity), 10993-5:2009 (Tests for in vitro cytotoxicity), 10993-10:2010 (Tests for irritation and skin sensitization); and 10993-11:2006 (Tests for systemic toxicity) was considered; 3) ISO 7405:2008 / Amd 1:2013 Dentistry-- Evaluation of Biocompatibility of Medical Devices in Dentistry; and
-
Japan: PFSB/ELD/OMDE Notification No. 0301-1 Mar. 1, 2012; (as translated by 3M Health Care Japan, August 6, 2012).
The biocompatibility of Ketac Universal Aplicap has been assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is that Ketac Universal Aplicap is safe for its intended use.
Conclusion
Comparisons of indications for use, essential ingredients, technology, and physical and mechanical properties showed that Ketac Universal Aplicap is substantially equivalent to the predicate device.