(45 days)
The drill is used to pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement. The drills are used with a handpiece.
CeraDrill is a ceramic drill for the dental implantology made of a modern high performance ceramic. The drills are intended to be used with a handpiece. The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement.
CeraDrills within the new "CeraLine" is intended for use in implantology. These are made of high efficiency ceramics featuring an excellent cutting performance. The new CeraDrill offers the possibility of working without any metal, thus guaranteeing a biocompatible operation. Damages, as they occur in particular when disinfecting and cleaning steel burs with inappropriate agents, are now a thing of the past. The multifunctional ceramic drills are suited for initial preparation of the implant site axis and depth. The drills feature high initial sharpness and optimal cutting efficiency, thus achieving an effective material reduction. Due to their high efficiency toothing and the distinct tip-transversing blade, the drill has very good axial drilling properties for precise cutting without the need for prior use of a centering bur. The special twist drill blade geometry ensures smooth and precise operation. Moreover, the depth markings, which are lasered on to the working part in 2 mm intervals guarantee precise and safe control of the penetration depth. The CeraDrill family is available in diverse dimensions and shapes for the individual preparation on the osteotomy.
This is a submission for a 510(k) premarket notification for a dental device, specifically a bone-cutting instrument. These types of devices generally rely on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials as typically seen for novel medical devices or diagnostic algorithms. Therefore, the information provided focuses on non-clinical performance and technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Aspects from "Summary of technological Characteristics" & "Mechanical Stability") | Reported Device Performance (CeraDrill) |
|---|---|
| Energy used and/or delivered | Intended to be used in electrical powered hand pieces (Same as predicate) |
| Design | Two/three cutting flutes, external irrigation (Predicate device had internal/external irrigation) |
| Performance (Concenticity) | Ordinary concentricity (Same as predicate) |
| Corrosion Resistance | Corrosion resistive; not leading to decolourisation while reprocessing (Improved over predicate's limited resistance) |
| Materials | Zirconium oxide (ZrO2/Al2O3/Y2O3); single material, no coating, limited probability of abrasion (Advantage over predicate's coated stainless steel) |
| Biocompatibility | According ISO 7405 (Same as predicate) |
| Ability to be reprocessed | Can be used, cleaned, disinfected, and sterilized for at least 10 cycles (demonstrated in test report #06m1166) |
| Mechanical stability after reprocessing | Reprocessed in 100 cycles without significant loss of mechanical stability (details in chapter 18 d) |
| Thermal safety | Improved thermal safety; lower temperature rise observed with ceramic burs compared to steel burs (details in chapter 18 a) |
| Resistiveness against bending forces | Assumable lower resistiveness against bending forces during operation is negligible (fracture would lead to unacceptable osteotomies/misuse) |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not specify a "test set" in the context of an AI/ML algorithm or a diagnostic test with patient data. Instead, it refers to non-clinical tests conducted on the CeraDrill devices themselves to evaluate their physical and biological characteristics. The data provenance is internal testing by the manufacturer (Gebr. Brasseler GmbH & Co. KG), and the studies are prospective in the sense that they were designed and executed to test the characteristics of the new device. No geographical origin of patient data is relevant here as it's not a clinical study involving patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study that involves expert review for ground truth in the context of diagnostic accuracy. The "ground truth" for the non-clinical tests would be the measured physical and biological properties of the device, assessed using established engineering and laboratory standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this submission describes non-clinical performance data, not a study evaluating human interpretation or a diagnostic outcome requiring adjudication.
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
No MRMC comparative effectiveness study was done. This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the evaluation of the CeraDrill's performance is based on engineering and laboratory test results for mechanical stability, thermal safety, corrosion resistance, material composition, and biocompatibility, as determined by internal testing and adherence to relevant standards (e.g., ISO 7405 for biocompatibility).
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
{0}------------------------------------------------
Premarket notification 510(k) submission Gebr. Brasseler Gmbh & Co KG CeraDrill K:
JUN 2 9 100
10(k) Summarv
Gebr. Brasseler GmbH & Co. KG owner's name: address: Trophagener Weg 25 32631 Lemgo Germany phone: + 49 5261 701 467 fax numbers: + 49 5261 701 289 Mr. Olaf Brand name of contact person: date the summary was prepared: February 2007 Establishment Registration number: 8010468 name of the device: CeraDrill trade or proprietary name: CeraDrill the classification name: Bone cutting instrument and accessories (21 CFR 872.4120 Product Code DZI)
Date: 2007-02-01 Revision: 3 Chapter 05 1/8 Page:
{1}------------------------------------------------
Nobel Biocare USA, Inc.
Device:
Amorphous Diamond Coated Drill
510(k) No.:
Description of the device:
CeraDrills within the new "CeraLine" is intended for use in implantology. These are made of high efficiency ceramics featuring an excellent cutting performance. The new CeraDrill offers the possibility of working without any metal, thus guaranteeing a biocompatible operation. Damages, as they occur in particular when disinfecting and cleaning steel burs with inappropriate agents, are now a thing of the past. The multifunctional ceramic drills are suited for initial preparation of the implant site axis and depth. The drills feature high initial sharpness and optimal cutting efficiency, thus achieving an effective material reduction. Due to their high efficiency toothing and the distinct tip-transversing blade, the drill has very good axial drilling properties for precise cutting without the need for prior use of a centering bur. The special twist drill blade geometry ensures smooth and precise operation. Moreover, the depth markings, which are lasered on to the working part in 2 mm intervals guarantee precise and safe control of the penetration depth.
The CeraDrill family is available in diverse dimensions and shapes for the individual preparation on the osteotomy. The following table shows the REF numbers, diameters, penetration depth, shank types, number of cutting flutes:
05
{2}------------------------------------------------
Remark:
further explanations concerning the columns of the following
table can be found in chapter 11 of this submission
| Model | REF /"Bezeichnung" | ID Nr. /IdentNr. | Description | Diameter /SØK Kopf-durch-messer" | penetrationdepth / KL"Kopflänge" | Totallength/Gesamt-länge | ShanktypeISO1797 | ShanktypeUS | Cuttingflutes/Schnei-denzahl |
|---|---|---|---|---|---|---|---|---|---|
| K210L16.RA.020 | K210L16.204.020 | 033792 | CeraDrillpilot drill2,0 L16 | 2,0 mm | 16,0 mm | 30,5 mm | 204 | RA | 2 |
| K210L19.RA.020 | K210L19.204.020 | 033793 | CeraDrillpilot drill2,0 L19 | 2,0 mm | 19,0 mm | 33,5 mm | 204 | RA | 2 |
| K210L16.RA.028 | K210L16.204.028 | 033794 | CeraDrillpilot drill2,8 L16 | 2,8 mm | 16,0 mm | 32,0 mm | 204 | RA | 3 |
| K210L19.RA.028 | K210L19.204.028 | 033795 | CeraDrillpilot drill2,8 L19 | 2,8 mm | 19,0 mm | 35,0 mm | 204 | RA | 3 |
| K210L20.RASL.020 | K210L20.205.020 | 034899 | CeraDrillpilot drill2,0 L20 | 2,0 mm | 20,6 mm | 41,0 mm | 205 | RASL | 2 |
| K210L20.RASL.028 | K210L20.205.028 | 034900 | CeraDrillpilot drill2,8 L20 | 2,8 mm | 20,84 mm | 41,0 mm | 205 | RASL | 3 |
| K210L20.RASL.035 | K210L20.205.035 | 035211 | CeraDrillpilot drill3,5 L20 | 3,5 mm | 21,05 mm | 41,0 mm | 205 | RASL | 3 |
| K210L20.RASL.042 | K210L20.205.042 | 035212 | CeraDrillpilot drill4,2 L20 | 4,2 mm | 21,26 mm | 41,0 mm | 205 | RASL | 3 |
Date: 2007-02-01 Revision: 3 Chapter
{3}------------------------------------------------
Intended use:
CeraDrill is a ceramic pilot drill for the dental implantology made of a modern high performance ceramic. The drills are intended to be used with a handpiece.
-
Indications for use .
The drill is used to pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement. The drills are used with a handpiece. -
Target population
The target population for the CeraDrill are Patients applicable for dental treatment with endosseous implants CeraDrill is used in the following anatomical sites: maxilla or mandible
CeraDrill is intended to be used at the Dentist
The device is an integral part of any implantological preparation.
Due to the fact that the device is intended to be used in the framework of the dental implantology the patients must be applicable for dental treatment with endosseous implants.
05
{4}------------------------------------------------
Summary of technological Characteristics
(compared to the predicate device)
The following table shows the technological characteristics of both
devices:
.
| Aspect | New device | Predicate device |
|---|---|---|
| CeraDrill | Amorpheus Diamondcoated drill | |
| energy used and/ordelivered | The device is intended tobe used in electricalpowered hand pieces | same |
| design | two / three cutting flutesexternal irrigation | two / three cutting flutesinternal /externalirrigation |
| performance | Ordinary concentricity | Ordinary concentricity |
| corrosion | Corrosion resistiveAdvantage:not leading to decolouri-sation while reprocessing | Limited corrosionresistance for stainlesssteel |
| materials | The CeraDrill is made ofZrO2/Al2O3/Y2O3Advantage:- just one material- no coating- limited probability ofabrasion due toinadequate bonding | stainless steelcoated with diamond |
| Biocompatibility | According ISO 7405 | same |
Date: 2007-02-01 Revision: 3 Chapter 05 Page: 5/8
:
:
:
:
: ﺗﺒ ......... :
:
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Premarket notification 510(k) submission Gebr. Brasseler Gmbh & Co KG K: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------CeraDrill ..
:
| Aspect | New device | Predicate device |
|---|---|---|
| Ability to bereprocessed | CeraDrill | Amorpheus Diamondcoated drill |
| The CeraDrill can beused, cleaned,disinfected and sterilisedaccording to thespecifications as given inthe instructions for usefor at least 10 cycles.(see test report# 06m1166 inchapter 14A of thissubmission) | No limitation forreprocessing indicated | |
| Mechanical stabilityafter reprocessing | CeraDrill may bereprocessed in 100cycles without asignificant loss ofmechanical stability(details see chapter 18 d) | No further explanation /information given |
| thermal safety | Improved thermal safety | |
| Advantage: | ||
| It was observed that the | ||
| temperature rise when | ||
| using ceramic burs waslower than that observedwith steel burs | ||
| (details see chapter 18 a) |
:
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:
: 上一篇:
:
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Page: ୧ାଃ
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Substantial equivalence determination
Non-clinical performance data:
The determination of substantial equivalence is based on several nonclinical tests, most of which are repeated in the body of this 510(k) submission.
This includes especially those tests showing the physical and biological characteristics. The test results can be summarised as follows:
- General technological equivalence between predicate and current device
- improved thermal safety -
- improved safety concerning the risk of inadequate bonding of the coating
- the assumable lower resistive ness against bending forces during operation is negligible, since those bending force being necessary for fracture would lead to unacceptable osteotomies (=misuse)
(Details on non-clinical test can be found in chapter 18 of this submission)
Clinical performance data
The determination of substantial equivalence is not based on clinical data.
{7}------------------------------------------------
Conclusion:
The main intention of the CeraDrill is to pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement. As such the CeraDrill can be concluded to be substantial equivalent to the predicate device:
Amorphous Diamond Coated Drill, Nobel Biocare, K990846
The only technical difference is the material used: whereas the predicate device is made of steel and coated with amorphous diamond the CeraDril is made of a single material which is Zirconium oxide.
This technological difference leads to the following advantages of the CeraDrill device:
-
Metalfree preparation
-
positve Osteointgration
-
non allgergenic compared to CrNi Steal
There is no known disadvantage; the known difference in the bending strength of the materials does not have an impact in the intended use as identified in the chapter 18 of the submission.
The safety and performance data submitted in this file support a finding of substantial equivalence between the CeraDrill and the predicate device as specified above.
Any other information:
none
{8}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gebr. Brasseler GmbH & Company KG C/O Mr. Olaf Brand TUV Rheinland of North America, Incorporated 12 Commerce Road Newtown, Connecticut 06470
JUN 2 9 2007
Re: K071352
Trade/Device Name: CeraDrill Regulation Number: 21 CFR 872.4130 Regulation Name: Intraoral Dental Drill Regulatory Class: I Product Code: EJL Dated: June 25, 2007 Received: June 27, 2007
Dear Mr. Brand:
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.
{9}------------------------------------------------
Page 2 - Mr. Brand
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" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runore
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
K0713352
Indications for Use
510(k) Number (if known): 1007 12 50
Device Name: CeraDrill
-
. Indications for use
The drill is used to pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement. The drills are used with a handpiece. -
specific indications:
CeraDrill is a ceramic drill for the dental implantology made of a modern high performance ceramic. The drills are intended to be used with a handpiece. The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. -
clinical settings / target population: · .
Patients must be applicable for dental treatment with endosseous implants. -
anatomical sites: .
The products are used in the framework of dental implantology for the preparation of the upper jaw (Maxilla) or the lower jaw
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Roose
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page I of 1
510(k) Number: K071352
§ 872.3240 Dental bur.
(a)
Identification. A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.