← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K060684 # ADPER PROMPT, ADPER PROMPT L-POP (K060684) _3M Espe AG Dental Products · KLE · Apr 24, 2006 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K060684 ## Device Facts - **Applicant:** 3M Espe AG Dental Products - **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md) - **Decision Date:** Apr 24, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3200 - **Device Class:** Class 2 - **Review Panel:** Dental ## Intended Use Bonding between dentin/enamel and composite filling materials Bonding between dentin/enamel and compomer filling materials Bonding mediator for fissure sealing Desensitization of hypersensitive areas of teeth Bonding between RelyX™ Fiber Post root posts and light-curing composite core build-up materials ## Device Story Adper Prompt/Adper Prompt L-Pop is a resin tooth bonding agent applied to prepared tooth cavities to improve restorative material retention; it also seals dentinal tubules to prevent hypersensitivity. The device is applied by dental professionals in a clinical setting. This submission adds a new indication: bonding RelyX™ Fiber Post (glassfiber-reinforced root canal posts) to light-curing composite core build-up materials. The chemical composition remains identical to the predicate (K040857). Performance testing confirms the agent's suitability for the new bonding application, providing a stable interface between the fiber post and core build-up material, thereby facilitating restorative dental procedures. ## Clinical Evidence Bench testing only. Performance and comparative testing were conducted to evaluate the bonding efficacy between RelyX™ Fiber Post root posts and light-curing composite core build-up materials. No clinical data was provided. ## Technological Characteristics Resin tooth bonding agent (21 CFR 872.3200). Chemical composition is identical to the predicate device (K040857). The device functions as a chemical adhesive for dental restorative materials and root canal posts. ## Regulatory 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. ## Predicate Devices - Adper™ Prompt™, Adper™ Prompt™ L-Pop™ ([K040857](/device/K040857.md)) - Adper™ Single Bond Plus ([K962785](/device/K962785.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS APR 2 4 2006 | Submitter | | |------------------------------------|---------------------------------------------------| | Company: | 3M ESPE AG | | Street: | ESPE Platz | | ZIP-Code, City: | D-82229 Seefeld | | Federal State: | Bavaria | | Country: | Germany | | Establishment Registration Number: | 9611385 | | Official Correspondent: | Dr. Andreas Petermann, Manager Regulatory Affairs | | Phone: | 011-49-8152-700 1395 | | Fax: | 011-49-8152-700 1869 | | E-mail: | andreas.petermann@mmm.com | | Date: | March 09, 2006 | Name of Device | Proprietary Name: | Adper™ Prompt™ | |---------------------|--------------------------------------------| | | Adper™ Prompt™ L-Pop™ | | Classification Name | Resin tooth bonding agent is designated at | | | 21 C.F.R. §872.3200 as a Class II device. | | Common Name: | Dental Adhesive | Predicate Devices: Adper™ Prompt™, Adper™ Prompt™ L-Pop™ by 3M ESPE (K040857) Adper™ Single Bond Plus by 3M ESPE (K962785) {1}------------------------------------------------ ## Description for the Premarket Notification Adper Prompt/Adper Prompt L-Pop is classified as 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). Additionally, Adper Prompt/Adper Prompt L-Pop can be used to scal dentinal tubules of exposed root surfaces to prevent from dentinal hypersensitivity. Furthermore, as recent results show, Adper Prompt L-Pop is suited to bond RelyX™ Fiber Post, glassfiber-reinforced root canal posts by 3M ESPE, to light-curing composite core build-up materials. 3M ESPE submits this 510(k) premarket notification to seck clearance for this new indication for use. Performance and comparative testing of Adper Prompt/Adper Prompt L-Pop has been carried out. The results suggest that Adper Prompt/Adper Prompt L-Pop is a suitable agent for bonding between RelyX Fiber Post root posts, by 3M ESPE, and light-curing composite core build-up materials. The chemical composition of Adper Prompt/Adper Prompt L-Pop remained unchanged in comparison to 510(k) K040857. Performance data for Adper Prompt/Adper Prompt L-Pop in the indications for use already cleared by 510(k) are, therefore, not subject of this 510(k) submission. The data provided in this 510(k) submission shows that Adper Prompt/Adper Prompt L-Pop is substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 4 2006 Dr. Sabine Krischer Regulatory Affairs Specialist 3M ESPE AG ESPE Platz Seefeld, Bavaria D-82229 GERMANY Re: K060684 Trade/Device Names: Adper Prompt and Adper Prompt L-Pop Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 09, 2006 Received: March 15, 2006 Dear Dr. Krischer: 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 usc 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 mav. 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 - Dr. Sabine Krischer 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 Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Suze Chiu S. Lin, PhD 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K660684 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 Desensitization of hypersensitive areas of teeth Bonding between RelyX™ Fiber Post root posts and light-curing composite core build-up materials 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) y, General Hospi L.A. W.S KILGORE Page 1 of イ --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K060684](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K060684) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com