(45 days)
Not Found
No
The summary describes a ceramic dental drill and its physical properties and performance characteristics. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No
The device is a drill for creating an osteotomy, which is a surgical procedure. It does not exert a therapeutic effect on the body, but rather acts as a surgical tool.
No
This device is a surgical drill used for preparing an osteotomy for dental implant placement. Its function is to cut into bone, not to diagnose a condition or disease.
No
The device description clearly describes a physical drill made of ceramic material, intended for surgical use. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a ceramic drill used for cutting bone. This is a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
DZI, EJL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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)
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)
No clinical performance data was used for the determination of substantial equivalence.
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.
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
§ 872.3240 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.
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. /
Ident
Nr. | Description | Diameter /
SØK Kopf-
durch-
messer" | penetration
depth / KL
"Kopflänge" | Total
length/
Gesamt-
länge | Shank
type
ISO
1797 | Shank
type
US | Cutting
flutes/
Schnei-
denzahl |
|------------------|------------------------|--------------------------|-------------------------------------|----------------------------------------------|------------------------------------------|--------------------------------------|------------------------------|---------------------|------------------------------------------|
| K210L16.RA.020 | K210L16.204.020 | 033792 | CeraDrill
pilot drill
2,0 L16 | 2,0 mm | 16,0 mm | 30,5 mm | 204 | RA | 2 |
| K210L19.RA.020 | K210L19.204.020 | 033793 | CeraDrill
pilot drill
2,0 L19 | 2,0 mm | 19,0 mm | 33,5 mm | 204 | RA | 2 |
| K210L16.RA.028 | K210L16.204.028 | 033794 | CeraDrill
pilot drill
2,8 L16 | 2,8 mm | 16,0 mm | 32,0 mm | 204 | RA | 3 |
| K210L19.RA.028 | K210L19.204.028 | 033795 | CeraDrill
pilot drill
2,8 L19 | 2,8 mm | 19,0 mm | 35,0 mm | 204 | RA | 3 |
| K210L20.RASL.020 | K210L20.205.020 | 034899 | CeraDrill
pilot drill
2,0 L20 | 2,0 mm | 20,6 mm | 41,0 mm | 205 | RASL | 2 |
| K210L20.RASL.028 | K210L20.205.028 | 034900 | CeraDrill
pilot drill
2,8 L20 | 2,8 mm | 20,84 mm | 41,0 mm | 205 | RASL | 3 |
| K210L20.RASL.035 | K210L20.205.035 | 035211 | CeraDrill
pilot drill
3,5 L20 | 3,5 mm | 21,05 mm | 41,0 mm | 205 | RASL | 3 |
| K210L20.RASL.042 | K210L20.205.042 | 035212 | CeraDrill
pilot drill
4,2 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 Diamond | |
| coated drill | ||
| energy used and/or | ||
| delivered | The device is intended to | |
| be used in electrical | ||
| powered hand pieces | same | |
| design | two / three cutting flutes | |
| external irrigation | two / three cutting flutes | |
| internal /external | ||
| irrigation | ||
| performance | Ordinary concentricity | Ordinary concentricity |
| corrosion | Corrosion resistive | |
| Advantage: | ||
| not leading to decolouri- | ||
| sation while reprocessing | Limited corrosion | |
| resistance for stainless | ||
| steel | ||
| materials | The CeraDrill is made of | |
| ZrO2/Al2O3/Y2O3 |
Advantage:
- just one material
- no coating
- limited probability of
abrasion due to
inadequate bonding | stainless steel
coated with diamond |
| Biocompatibility | According ISO 7405 | same |
Date: 2007-02-01 Revision: 3 Chapter 05 Page: 5/8
:
:
:
:
: ﺗﺒ ......... :
:
5
Premarket notification 510(k) submission Gebr. Brasseler Gmbh & Co KG K: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------CeraDrill ..
:
| Aspect | New device | Predicate device |
|---|---|---|
| Ability to be | ||
| reprocessed | CeraDrill | Amorpheus Diamond |
| coated drill | ||
| The CeraDrill can be | ||
| used, cleaned, | ||
| disinfected and sterilised | ||
| according to the | ||
| specifications as given in | ||
| the instructions for use | ||
| for at least 10 cycles. | ||
| (see test report# 06m1166 in | ||
| chapter 14A of this | ||
| submission) | No limitation for | |
| reprocessing indicated | ||
| Mechanical stability | ||
| after reprocessing | CeraDrill may be | |
| reprocessed in 100 | ||
| cycles without a | ||
| significant loss of | ||
| mechanical 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 was | ||
| lower than that observed | ||
| with steel burs | ||
| (details see chapter 18 a) |
:
:
: .
:
: 上一篇:
:
. : :
Page: ୧ାଃ
6
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