(47 days)
- Bonding between dentin/enamel and composite filling materials
- Bonding between dentin/enamel and compomer filling materials
- Intraoral repair of porcelain, composite, and metal using light-cure composite resin.
- Desensitization of hypersensitive teeth, root surface desensitization
SEA2 Self-etch adhesive is a simple to use, two-bottle, self-etch bonding adhesive with bottle A containing the aqueous primer and bottle B containing the acidic adhesive. This delivery design is common to many of the predicate devices as noted in the submission. The primer contains a color indicator which indicates complete coverage of the preparation. The color disappears upon addition of the adhesive, indicating activation of the acid and insuring that a proper etch is taking place.
The provided text describes a 510(k) submission for the SEA2 Self-Etch Adhesive, a dental device. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific quantitative acceptance criteria or reporting detailed performance against such criteria. Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, and performance metrics cannot be found in the provided document.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Established/Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | "The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405." |
| Performance (Adhesion to Dentin and Enamel) | "The performance testing includes adhesion to dentin and enamel. The test results provided in the submission confirm the performance as substantially equivalent to the predicate devices with common indications." |
| Substantial Equivalence to Predicate Devices | "The chemical composition is similar to predicate self-etch adhesive devices." |
| "The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405." | |
| "The test results provided in the submission confirm the performance as substantially equivalent to the predicate devices with common indications." |
Missing Information:
- Specific quantitative acceptance criteria (e.g., minimum bond strength in MPa, maximum cytotoxicity thresholds).
- Detailed quantitative performance results (e.g., actual bond strength values, specific cytotoxicity assay results).
- Details on "common indications" where performance was confirmed.
2. Sample size used for the test set and the data provenance
Missing Information:
- The document does not specify the sample size used for performance testing (e.g., how many teeth or samples were tested for adhesion).
- The data provenance (e.g., country of origin, retrospective or prospective) for the test set is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable/Missing Information:
- This type of information is typically relevant for diagnostic devices where "ground truth" might be established by expert interpretation of images or clinical findings. For a dental adhesive, ground truth is established through laboratory performance testing (e.g., bond strength measurements, biocompatibility assays) rather than expert consensus on interpretations. The document does not mention human experts establishing ground truth for the test set.
4. Adjudication method for the test set
Not Applicable/Missing Information:
- Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies. For laboratory performance testing of a dental adhesive, this concept does not apply.
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:
- MRMC studies are relevant for diagnostic devices, especially those involving AI for image interpretation. This device is a dental adhesive, and no AI component or human reader interpretation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable:
- This pertains to AI algorithms. The SEA2 Self-Etch Adhesive is a physical dental bonding agent, not an AI algorithm.
7. The type of ground truth used
- For Biocompatibility: Ground truth was established through biocompatibility assessment based on ISO10993 and ISO 7405. This implies specific laboratory tests and their established pass/fail criteria according to these international standards.
- For Performance (Adhesion): Ground truth was established through adhesion testing to dentin and enamel. This would involve laboratory measurements of bond strength, likely against established benchmarks or in comparison to predicate devices.
Missing Information:
- Specific details of the ground truth (e.g., what specific ISO tests were performed, the exact lab methods for adhesion testing, specific numerical thresholds).
8. The sample size for the training set
Not Applicable/Missing Information:
- The concept of a "training set" is primarily relevant for machine learning or AI algorithms. For a conventional medical device like a dental adhesive, there isn't a "training set" in this context. Product development and formulation might involve iterative testing, but it's not described as a "training set" with ground truth in the AI sense.
9. How the ground truth for the training set was established
Not Applicable/Missing Information:
- As explained above, there is no "training set" for this type of device in the context of AI or machine learning.
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3M ESPE Dental Products
3M Center St. Paul, MN 55144-1000 651 733 1110
Image /page/0/Picture/2 description: The image shows the logo for 3M ESPE. The logo is in black and white. The text is in a sans-serif font and is bolded.
MAY 2 2 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
Company: Street: ZIP-Code, City: Country: Establishment Registration Number: Official Correspondent:
Phone: Fax: E-mail. Date:
Name of Device
Proprietary Name: Classification Name
Common Name:
3M ESPE Dental Products 3M Center St. Paul, Mn 55144 USA 2110898 Karen O'Mallev Sr. Regulatory Specialist 651 736-7326 651 737-6049 kdomalley@mmm.com March 09, 2007
SEA2 Resin tooth bonding agent 21 C.F.R. §872.3200 as a Class II device. Dental Adhesive
Predicate Devices
| Device | 510(k) |
|---|---|
| Adper Single Bond Plus | K962785 |
| K060684 | |
| K040857 | |
| Adper Prompt | K020946 |
| K023842 | |
| K012442 | |
| Clearfil SE Bond | K990040 |
Description and Technology Eguivalence
SEA2 Self-etch adhesive is classified as Resin tooth bonding agent (21 C.F.R§872.3200) because it is a device intended to be applied to the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). SEA2 is also indicated for intraoral repairs of composite resin, porcelain or metal using light-cured composite resin. SEA2 can be used to seal dentinal tubules of hypersensitive teeth and exposed root surfaces to treat dentinal hypersensitivity.
SEA2 Self-etch adhesive is a simple to use, two-bottle, self-etch bonding adhesive with bottle A containing the aqueous primer and bottle B containing the acidic adhesive. This delivery design is common to many of the predicate devices as noted in the submission. The primer contains a color indicator which indicates complete coverage of the preparation. The color disappears upon addition of the adhesive, indicating activation of the acid and insuring that a proper etch is taking place.
Substantial safety and comparative performance testing of SEA2 has been conducted. The chemical composition is similar to predicate self-etch adhesive devices. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405.
The performance testing includes adhesion to dentin and enamel. The test results provided in the submission confirm the performance as substantially equivalent to the predicate devices with common indications.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing the body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2007
Ms. Karen O'Malley Sr. Regulatory Specialist 3M ESPE Dental Products 3M Center St. Paul, Minnesota 55144-1000
Re: K070956
Trade/Device Name: SEA2 Self Etch Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 30, 2007 Received: April 05, 2007
Dear Ms. O'Malley:
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.
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Page 2 - Ms. Karen O'Malley
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smith Y. Michael Davis
Chiú 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
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Indications for Use
510(k)Number: K070956
Device Name: SEA2 Self Etch Adhesive
Indications For Use:
-
Bonding between dentin/enamel and composite filling materials
-
Bonding between dentin/enamel and compomer filling materials
-
Intraoral repair of porcelain, composite, and metal using light-cure composite resin.
-
Desensitization of hypersensitive teeth, root surface desensitization
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE: IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Roi My for MSR
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ion of Anesthesiology, General Hospital,
ion of Anesthesiology, General
ction Control, Dental Devices
K070956
) Number
Page 1 of
§ 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.