(10 days)
Bonding between dentin/enamel and composite filling materials.
Bonding between dentin/enamel and compomer filling materials.
Bonding mediator for fissure sealing
Bonding mediator for bracket attachment
Adper Prompt is classified as a Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material).
Adper Prompt will be available in single dose applicators, "Adper Prompt L-Pop". Additionally, Adper Prompt will also be available in a two-vial version called "Adper Prompt". The resulting bonding agent, regardless if obtained from L-Pop application system or two-vial system, has the same chemical composition and material characteristics.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Adper Prompt device:
Acceptance Criteria and Device Performance for Adper Prompt
The provided 510(k) summary for Adper Prompt does not explicitly state numerical acceptance criteria tied to specific performance metrics (e.g., minimum bond strength in MPa). Instead, the acceptance philosophy hinges on demonstrating substantial equivalence to the predicate device, Prompt L-Pop. The core of the "study" described is a comparative performance study against this predicate.
Table 1: Acceptance Criteria (Implied) and Reported Device Performance
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility to be equivalent to predicate. | "Additionally, an independent research institute carried out biocompatibility testing. The results show that Adper Prompt is a safe device." (Implied to be comparable or superior to predicate, as it's deemed "safe"). |
| Effectiveness: Performance characteristics to be equivalent to predicate (Prompt L-Pop). | "To prove the effectiveness of Adper Prompt, the performance characteristics of Adper Prompt were compared to Prompt L-Pop." (Detailed results of this comparison are not provided in the summary, only the statement that the comparison was done and implied to meet equivalence for the device to be cleared.) The submission concludes that the device is "substantially equivalent to the predicate device" based on these comparisons, among other factors. |
| Chemical Composition: Minor changes, but basic design remains the same, leading to same final composition and material characteristics. | "The modifications of Prompt L-Pop concern minor changes of the chemical composition, however, the basic chemical design remains the same." "The resulting bonding agent, regardless if obtained from L-Pop application system or two-vial system, has the same chemical composition and material characteristics." "Adper Prompt incorporates the same basic chemical design." |
| Intended Use: Same as predicate. | "Adper Prompt has the same intended use." |
| Shelf Life: Same as predicate. | "Adper Prompt has the same shelf life." |
Missing Information: It's crucial to note that the provided 510(k) summary is very high-level regarding the actual efficacy data. It asserts a comparison was made and that equivalence was found, but it does not include any specific performance metrics (like bond strength values, leakage rates, etc.) or confidence intervals that would typically be associated with a robust clinical or bench study.
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in the provided summary.
- Data Provenance: The biocompatibility testing was carried out by "an independent research institute." The location/country of this institute, whether the studies were retrospective or prospective, or details about the "performance characteristics" comparison are not provided. Given the submitter is from Germany, it's possible the testing was also conducted in Germany or a European country.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. This device is a resin tooth bonding agent, not a diagnostic imaging device that typically uses human experts to establish ground truth from medical images. The "ground truth" for this device would be established through objective laboratory testing (e.g., tensile bond strength, microleakage, etc., and biocompatibility assays), not expert consensus on interpretations.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2. Adjudication methods are relevant for studies involving human interpretation where discrepancies need to be resolved. Performance of this device is assessed through laboratory methods.
-
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. This is not an AI-assisted diagnostic device. Therefore, MRMC studies and AI-related effect sizes are irrelevant to this product submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device. Its performance is assessed as a standalone material.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for proving effectiveness and safety would be established through benchtop laboratory testing for material properties and performance (e.g., bond strength to dentin/enamel, microleakage studies, setting time, solubility) and in vitro/in vivo biocompatibility testing as per ISO standards. The summary only generally states "biocompatibility testing" and comparison of "performance characteristics."
-
The sample size for the training set:
- Not Applicable. This is a material-based device, not a machine learning or AI device that relies on a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.
Submitter
APR 0 4 2002
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas PetermannManager U.S. Regulatory Affairs |
| Phone: | 01149-8152-700 1395 |
| Fax: | 01149-8152-700 1869 |
| E-mail: | Andreas.Petermann@mmm.com |
| Date of Submission: | March 22, 2002 |
Name of Device
| Proprietary Name: | Adper Prompt |
|---|---|
| Classification Name: | Resin Tooth Bonding Agent |
Common Name: .................................................................................................................................................................
Predicate Device:
Prompt L-Pop .................................................................................................................................................................
Description for the Premarket Notification
Adper Prompt is classified as a Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material).
Image /page/0/Picture/10 description: The image shows the text "Special 510(k) Adper TM Prompt TM" at the top. Below that is the text "3M ESPE" in a larger, bold font. The text is black and the background is white. The image appears to be a logo or product name.
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3M ESPE is submitting this Special 510(k) for modifications to the All-In-One Adhesive Prompt L-Pop.
The modifications of Prompt L-Pop concern minor changes of the chemical composition, however, the basic chemical design remains the same.
Like Prompt L-Pop, Adper Prompt will be available in single dose applicators, "Adper Prompt L-Pop". Additionally, Adper Prompt will also be available in a two-vial version called "Adper Prompt". The resulting bonding agent, regardless if obtained from L-Pop application system or two-vial system, has the same chemical composition and material characteristics.
The modified bonding agent Adper Prompt has the following similarities to the unmodified Prompt L-Pop:
- . Adper Prompt has the same intended use.
- . Adper Prompt incorporates the same basic chemical design.
- . Adper Prompt has the same shelf life.
To provide evidence for safety, the chemical composition of Adper Prompt was compared to Prompt L-Pop. Additionally, an independent research institute carried out biocompatibility testing. The results show that Adper Prompt is a safe device.
To prove the effectiveness of Adper Prompt, the performance characteristics of Adper Prompt were compared to Prompt L-Pop.
In summary, the modified dental adhesive Adper Prompt described in this Special 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate device.
Image /page/1/Picture/10 description: The image shows the logo for 3M ESPE. The logo is in black and white. Above the logo, the text "Special 510(k) Adper TM Prompt TM" is written in a smaller font.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz D-82229 Seefeld Bavaria, GERMANY
APR 0 4 2002
Re: K020946
Trade/Device Name: Adper Prompt Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EMA Dated: March 22, 2002 Received: March 25, 2002
Dear Dr. Petermann:
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 - Dr. Petermann
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dris assumes a your device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must of any I ederal statutes and regulations and admited to: registration and listing (21 Comply with an the 10th 010th 2011); good manufacturing practice requirements as set CI'N in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by bound (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) I mis icher will anow you to begin maing of substantial equivalence of your device to a legally premits to the are in the Pressification 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 and If you desire specific arr 809.10 for in vitro diagnostic devices), please contact the Office of adminity 21 OF F F art For 613. Additionally, for questions on the promotion and advertising of Compinance at (301) 591 to the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entities, "Thisoftanang on your responsibilities under the Act may be obtained from the Other general information 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,
Ky Whitlock
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
(As Required by 21 C.F.R. § 801.109)
510(k) Number:
Device Name:
Adper Prompt
Indications for use:
Bonding between dentin/enamel and composite filling materials.
Bonding between dentin/enamel and compomer filling materials.
Bonding mediator for fissure sealing
Bonding mediator for bracket attachment
Division Sign Off
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription use: □
Over-the counter use □
§ 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.