(37 days)
As a Universal Self-Etching Adhesive System, ALL-IN-ONE Adhesive, as the name implies, is the only product one needs to etch, prime, and bond to a tooth structure and dental substrates.
ALL-IN-ONE is used for:
- Direct restorations (composite, amalgam)
- All indirect restorations (composite, metal, porcelain)
- Desensitization of crown preparations prior to impression making/provisionalization
- Composite core build-ups
- Composite to metal/set amalgam (direct veneering)
- Root desensitization
- New amalgam to existing amalgam
- Repairs (composite-to-composite, composite-to-porcelain)
As a Universal Self-Etching Adhesive System, ALL-IN-ONE Adhesive, as the name implies, is the only product one needs to etch, prime, and bond tooth structure. It is a twocomponent, single step adhesive system. ALL-IN-ONE is a light cure system that may be used for bonding both light-cure and self-cure composites, porcelain, and metal. ALL-IN-ONE may also be used for desensitization of tooth structures.
The provided document is a 510(k) Summary for a dental adhesive (ALL-IN-ONE) and describes its substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance data like an AI/ML device would. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Not applicable for this type of submission)
The document does not specify quantitative acceptance criteria or a reported device performance in the way an AI/ML device would, which might involve metrics like sensitivity, specificity, or AUC. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, chemical composition, and mechanical/physical properties.
| Property | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ALL-IN-ONE) |
|---|---|---|
| Intended use | Self-Etching, Single Step Dental Adhesive (PROMPT L-POP) | Self-Etching, Single Step Dental Adhesive |
| Multi-Step Dental Adhesive (ALL-BOND 2) | ||
| Chemical composition | Light-cure, unfilled, multifunctional methacrylate based resin (PROMPT L-POP) | Light-cure, unfilled, multifunctional methacrylate based resin |
| Dual-cure, unfilled, multifunctional methacrylate based resin (ALL-BOND 2) | ||
| Mechanical /physical properties | Low viscosity, yellow colored dental etching, priming, and bonding agent (PROMPT L-POP & ALL-BOND 2) | Medium viscosity, light pink colored dental etching, priming, and bonding agent |
| Oral Toxicity | Non-toxic | Non-toxic |
Explanation: The "acceptance criteria" here are implicitly met by demonstrating similar attributes to the predicate devices. The "reported device performance" is a description of ALL-IN-ONE's characteristics. The submission emphasizes that "side by side comparisons... clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices."
Study Details (Not applicable for this type of submission)
Since this is a submission for a dental adhesive demonstrating substantial equivalence, not an AI/ML device with performance studies, the following categories are not applicable and cannot be extracted from the provided text.
- Sample size used for the test set and the data provenance: Not applicable. No test set of clinical data from patients is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a test set of clinical data is established.
- Adjudication method for the test set: Not applicable.
- 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/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the safety of the device was "oral toxicity testing" which found it to be non-toxic. For efficacy, the ground truth is established by its chemical and physical similarity and intended uses aligning with the predicate devices which are already deemed safe and effective.
- The sample size for the training set: Not applicable. No training set for an algorithm is discussed.
- How the ground truth for the training set was established: Not applicable.
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APR 2 0 2005
Section 5 510 (k) SUMMARY
| Applicant: | Bisco, Inc. |
|---|---|
| 1100 W. Irving Park Road | |
| Schaumburg IL, 60193 | |
| Contact Person: | Benjamin Lichtenwalner |
| Tel: 847-534-6146 | |
| Fax: 847-534-6111 | |
| Date Prepared: | November |
| Trade Name: | ALL-IN-ONE |
| Common Name: | Dental Adhesive |
| Classification/Name: | Resin Tooth Bonding Agent |
| Class II per 21 CFR 872.3200 |
Description of Applicant Device:
As a Universal Self-Etching Adhesive System, ALL-IN-ONE Adhesive, as the name implies, is the only product one needs to etch, prime, and bond tooth structure. It is a twocomponent, single step adhesive system. ALL-IN-ONE is a light cure system that may be used for bonding both light-cure and self-cure composites, porcelain, and metal. ALL-IN-ONE may also be used for desensitization of tooth structures.
Intended uses of Applicant Device:
The principle uses of the ALL-IN-ONE Adhesive is to etch, prime, and bond for direct and indirect restorations involving dentin, enamel, light-cure and self-cure composites, amalgam/metals, porcelain, and core build-ups. ALL-IN-ONE can also be used for desensitization of tooth structures such as hypersensitive dentin/enamel and exposed root surfaces.
Predicate Devices:
Prompt L-Pop from ESPE Dental AG, cleared under K001494 dated May 9, 2000.
All-Bond 2 from Bisco, Inc, cleared under K910860 dated April 29, 1991.
Page 5-1
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Section 5 510 (k) SUMMARY (continued)
Significant Performance Characteristics:
PROMPT L-POP to ALL-IN-ONE
| Property | PROMPT L-POP | ALL-IN-ONE |
|---|---|---|
| Intended use | Self-Etching, Single Step DentalAdhesive | Self-Etching, Single StepDental Adhesive |
| Chemical composition | Light-cure, unfilled, multifunctionalmethacrylate based resin. | Light-cure, unfilled, multifunctionalmethacrylate based resin. |
| Mechanical /physicalproperties | Low viscosity, yellow coloreddental etching, priming, andbonding agent. | Medium viscosity, light pinkcolored dental etching, priming,and bonding agent. |
ALL-BOND 2 SYSTEM to ALL-IN-ONE
| Property | ALL-BOND 2 SYSTEM | ALL-IN-ONE |
|---|---|---|
| Intended use | Multi-Step Dental Adhesive | Single Step Dental Adhesive |
| Chemical composition | Dual-cure, unfilled, multifunctionalmethacrylate based resin. | Light-cure, unfilled, multifunctionalmethacrylate based resin. |
| Mechanical /physicalproperties | Low viscosity, yellow coloreddental etching, priming, andbonding agent. | Medium viscosity, light pinkcolored dental etching, priming,and bonding agent. |
Side by side comparisons of ALL-IN-ONE to the predicate devices PROMPT L-POP and ALL-BOND 2 SYSTEM clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. ALL-IN-ONE was tested for oral toxicity and was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of ALL-IN-ONE.
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APR 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K050647
Trade/Device Name: ALL-IN-ONE Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 11, 2005 Received: March 14, 2005
Dear Mr. Lichtenwalner:
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 - Mr. Benjamin Lichtenwalner
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.
Susan Punnes
ﮏ 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
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510 (k) Number (if known):
ALL-IN-ONE Device Name:
Indications for Use:
As a Universal Self-Etching Adhesive System, ALL-IN-ONE Adhesive, as the name implies, is the only product one needs to etch, prime, and bond to a tooth structure and dental substrates.
1 05064
ALL-IN-ONE is used for:
-
- Direct restorations (composite, amalgam)
-
- All indirect restorations (composite, metal, porcelain)
-
- Desensitization of crown preparations prior to impression making/provisionalization
-
- Composite core build-ups
-
- Composite to metal/set amalgam (direct veneering)
-
- Root desensitization
-
- New amalgam to existing amalgam
-
- Repairs (composite-to-composite, composite-to-porcelain)
Prescription Use / (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swoon Kumar
Asion Sign-Off) ision of Anesthesiology, Genera cention Control. Dental D
§ 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.