(40 days)
Not Found
No
The 510(k) summary describes a kit of dental materials (bonding agents, flowable compomer, flowable composite) for repairing and restoring teeth. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device components are indicated for bonding, repairs, restorations, and sealing, not for treating or preventing disease. While "treatment of hypersensitive teeth" is mentioned, the primary function of the bonding agent is to seal the dentin tubules, which is a restorative action rather than a direct therapeutic one to address the underlying cause of hypersensitivity.
No
The device is a kit of dental materials (bonding agents, compomers, and composites) used for restorations and repairs of teeth, not for diagnosing conditions or diseases.
No
The device description clearly lists four physical materials (bonding agents, flowable compomer, flowable composite) that constitute the device. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses described are for dental procedures involving bonding, repairing, and restoring tooth structure and existing dental materials. These are all applications performed directly on or within the patient's mouth.
- Device Description: The materials described are bonding agents and flowable restorative materials used in dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use in a dental setting.
N/A
Intended Use / Indications for Use
The Composite/Compomer Repair Kit consists of 4 materials:
-
- a general 6th generation bonding agent for enamel and dentin,
-
- a special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
-
- a flowable compomer and
-
- a flowable composite
Bonding System (Contax) is indicated for
- bonding chemically cured, light cured, or dual cured resin-based . materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel)
- treatment of hypersensitive teeth .
Composite Repair MMA-free is indicated
- as a bonding agent for the intra- or extraoral repair of poor or damaged . resin-based materials restorations
- as a bonding agent for composite-based posts .
- for shade corrections of esthetically unsatisfying restorations .
- for repair and completion of temporary crowns and bridges .
- as a bonding agent on resin-based materials .
PrimaFlow is indicated for
- minimally invasive restorations
- Class III and V restorations .
- bases .
- extended fissure sealing
- restorations of all classes of cavities in deciduous teeth .
- as a temporary luting cement for e.g. veneers, and .
- as a flowable compomer repair agent .
Flowable Composite (LuxaFlow) is indicated as
- as an aesthetic anterior restoration .
- a base restoration under posterior or anterior composites .
- an add-on or repair material for provisional crowns & bridges .
- for incorporation of most mechanically anchored attachment . components into the acrylic base of an overdenture or partial denture.
- as a temporary luting cement for e.g. veneers, and .
- as a flowable composite repair agent . .
Product codes (comma separated list FDA assigned to the subject device)
KLE, EBF
Device Description
The Composite/Compomer Repair Kit consists of 4 materials:
-
- A general 6" generation bonding agent for enamel and dentin,
-
- A special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
-
- A flowable compomer and
-
- A flowable composite
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure (dentin and enamel)
Indicated Patient Age Range
Not Found
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)
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's quidance document entitled Guidance for Industry and FDA Staff: Dental Composites -Premarket Notification (November 1998).
Conclusion: Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Composite/Compomer Repair Kit restorative materials have been shown to be safe and effective for its intended use.
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.
K002086, K970683, K992879, K001914, K012316, K012307, K003153, K845033, K023776, K022612
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
04196
AUG 3 0 2004 Attachment K 510(k) Summary
| Trade Name: | Composite/Compomer Repair Kit |
|---|---|
| Sponsor: | DMG USA, Inc. |
| 414 South State Street | |
| Dover, DE 19901 | |
| Registration # not yet assigned | |
| Owner/Operator No. 9005969 | |
| Device Generic Name: | Dental restorative material and bonding agent |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. |
Predicate Devices:
The proposed DMG-USA Composite/CompomerKit restorative material is substantially equivalent to several currently marketed dental restorative materials:
| Product Name | 510(k) # | Manufacturer |
|---|---|---|
| PrimaFlow | K002086 | DMG USA |
| Zenith Flowable Composite | K970683 | Foremost Dental Mfg. |
| Composite Repair | K992879 | DMG-Hamburg |
| Clearfill Repair | K001914 | Kuraray Co., Ltd. |
| PermaCem | K012316 | DMG USA |
| LuxaCore/uxaCore Dual | K012307 | DMG USA |
| Solobond Plus | K003153 | Voco |
| Tag Bong | K845033 | Foremost Dental Mfg. |
| Xeno III | K023776 | Dentsply |
| iBond | K022612 | Heraeus Kulzer |
Product Description/Indications for Use:
The Composite/Compomer Repair Kit consists of 4 materials:
-
- A general 6" generation bonding agent for enamel and dentin,
-
- A special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
-
- A flowable compomer and
-
- A flowable composite
Bonding System is indicated for
- . bonding chemically cured, light cured, or dual cured resin-based materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel)
- treatment of hypersensitive teeth .
1
Composite Repair MMA-free is indicated
- as a bonding agent for the intraoral repair of poor or damaged resin-based . materials composite restorations
- . as a bonding agent for composite-based posts
- . for shade corrections of esthetically unsatisfying restorations
- for repair and completion of temporary crowns and bridges .
- . as a bonding agent on resin-based materials
PrimaFlow is indicated for
- minimally invasive restorations .
- Class III and V restorations
- . bases
- . extended fissure sealing
- restorations of all classes of cavities in deciduous teeth .
- as a temporary luting cement for e.g. veneers, and .
- . as a flowable compomer repair agent .
Flowable Composite is indicated as
- as an aesthetic anterior restoration .
- a base restoration under posterior or anterior composites .
- . an add-on or repair material for provisional crowns & bridges
- . for incorporation of most mechanically anchored attachment components into the acrylic base of an overdenture or partial denture.
- . as a temporary luting cement for e.q. veneers, and
- . as a flowable composite repair agent .
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's quidance document entitled Guidance for Industry and FDA Staff: Dental Composites -Premarket Notification (November 1998).
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Composite/Compomer Repair Kit restorative materials have been shown to be safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2004
Ms. Pamela Papineau, RAC Consultant DMG USA, Incorporated 414 South State Street Dover, Delaware 19901
Re: K041960
Trade/Device Name: Composite/Compomer Repair Kit Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EBF Dated: June 15, 2004 Received: July 21, 2004
Dear Ms. Papineau:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 – Ms. Pamela Papineau, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be advisod that 1 27 × ination that your device complies with other requirements of the Act or that I Dri has mude a acternilations 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); an the Act 3 requirements) increased and manufacturing practice requirements as set forth in the quality fabething (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will acation. The FDA finding of substantial equivalence of your device to a legally premaince notification - results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you active of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, andraa votabling ogy and in
please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
"Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page of
510(k) Number (if known): K041960
Device Name: Composite/Compomer Repair Kit
Indications for Use:
The Composite/Compomer Repair Kit consists of 4 materials:
-
- a general 6th generation bonding agent for enamel and dentin,
-
- a special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
-
- a flowable compomer and
-
- a flowable composite
Bonding System (Contax) is indicated for
- bonding chemically cured, light cured, or dual cured resin-based . materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel)
- treatment of hypersensitive teeth .
Composite Repair MMA-free is indicated
- as a bonding agent for the intra- or extraoral repair of poor or damaged . resin-based materials restorations
- as a bonding agent for composite-based posts .
- for shade corrections of esthetically unsatisfying restorations .
- for repair and completion of temporary crowns and bridges .
- as a bonding agent on resin-based materials .
PrimaFlow is indicated for
- minimally invasive restorations �
- Class III and V restorations .
- bases .
- extended fissure sealing ●
- restorations of all classes of cavities in deciduous teeth .
- as a temporary luting cement for e.g. veneers, and .
- as a flowable compomer repair agent .
2 Page of
5
Flowable Composite (LuxaFlow) is indicated as
- as an aesthetic anterior restoration .
- a base restoration under posterior or anterior composites .
- an add-on or repair material for provisional crowns & bridges .
- for incorporation of most mechanically anchored attachment . components into the acrylic base of an overdenture or partial denture.
- as a temporary luting cement for e.g. veneers, and .
- as a flowable composite repair agent . .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the -Counter Use (21 CFR 807 Subpart D)
Suresh Kumar
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number. K941640