(47 days)
Not Found
No
The device description and other sections do not mention any AI or ML components or capabilities. The technology described is a chemical bonding agent.
No
The device is a bonding adhesive for dental applications and is primarily used for bonding and desensitization, not for treating or preventing disease in a therapeutic sense.
No
This device is a dental adhesive used for bonding and desensitization, not for diagnosing medical conditions. Its function is to facilitate the adhesion of dental filling materials and reduce tooth sensitivity.
No
The device description clearly states it is a "two-bottle, self-etch bonding adhesive with bottle A containing the aqueous primer and bottle B containing the acidic adhesive," indicating it is a chemical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description and intended uses of the SEA2 Self-etch adhesive clearly indicate it is a material used directly on the patient's teeth for bonding, repair, and desensitization. It is applied in vivo (within the living body), not used to test specimens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of bodily fluids or tissues, diagnostic information, or laboratory procedures typically associated with IVDs.
Therefore, this device falls under the category of a dental restorative or bonding material, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
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.
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
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)
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.
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.
K962785, K060684, K040857, K020946, K023842, K012442, K990040
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
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.
1
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.
2
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
3
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
gn-Off)
ion of Anesthesiology, General Hospital,
ion of Anesthesiology, General
ction Control, Dental Devices
K070956
) Number
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