(144 days)
elcomed 100
Not Found
No
The document describes a hand-held motor system for oral surgery and does not mention any AI or ML capabilities.
Yes
The device is used for various oral surgical procedures such as implant placement, bone grafting, tooth removal, periodontal surgeries, and endodontic treatments, all of which fall under therapeutic interventions.
No
Explanation: The provided text describes the device's indications for use as various surgical procedures (e.g., implant placement, bone grafting, tooth removal), and its components as a hand-held motor, foot control, and controller. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description explicitly states it consists of a hand-held motor, foot control, and controller, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the elcoMED SA-200 and SA-200 C clearly indicates it is a surgical device used for procedures within the oral cavity. It involves a motor, handpiece, and foot control for physical manipulation of bone and teeth.
- Intended Use: The listed indications for use are all surgical procedures performed directly on the patient's tissues (implant placement, bone grafting, tooth removal, periodontal surgeries, endodontic treatment). These are not tests performed on samples outside the body.
Therefore, the elcoMED SA-200 and SA-200 C is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Drive unit for surgical transmission instruments with coupling system according to DIN 13.940/ISO 3964 with the functions "mechanical drive" and "supply with coolant". It is indicated for use in dental, surgical procedures.
The Indications are very widespread in the field of oral surgery.
- A. Implant placement, including
-
- preparation of the osteotomy site
-
- bone reconturing, osteoplasty
-
- B. Bone grafting
-
- granns
- Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
-
- harvesting autogen living bone
-
- sinus elevation & grafting of alveolar sockets
-
- C. Removal and sectioning of teeth ant teeth bone for e.g. impacted third molars and complicated extractions
- D. Periodontal surgeries
-
- bone recontouring & alveoplasty around living teeth
-
- removal of exoslosis
-
- E. Endodontic treatment
-
- Intracanal preparations using rotating NiTi-files
-
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
elcoMED SA-200 and elcoMED SA-200 C consist of a small hand held motor, a foot control and a controller. The system components connect to each other via a proprietary coupling system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
elcomed 100
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
510(k) SUMMARY
W & H Dentalwerk Buermoos GmbH Submitted by: Ignaz-Glaser-Strasse 53 A-5111 Buermoos Austria
| Contact person: | Ralf Benda |
|---|---|
| Tel.: +43-6274-6236-0 | |
| Fax: +43-6274-6236-55 |
Date of Preparation:06/12/2001
elcoMED SA-200 and elcoMED SA-200 C Device name: Surgical unit for dental application Common name: Classification name: Controller, foot, handpiece and cord
Predicate device: elcomed 100
Device Description:
elcoMED SA-200 and elcoMED SA-200 C consist of a small hand held motor, a foot control and a controller. The system components connect to each other via a proprietary coupling system.
Intended use:
Drive unit for surgical transmission instruments with coupling system according to DIN 13.940/ISO 3964 with the functions "mechanical drive" and "supply with coolant". It is indicated for use in dental, surgical procedures.
Technological Characteristics:
elcoMED SA-200 and elcoMED SA-200 C is the update of elcomed 100 and provides various changes of the design, a calibration function (only type elcoMED SA-200 C) to increase accuracy of torque measurement and a possibility to save data on a card.
Substantial equivalence:
elcoMED SA-200 and elcoMED SA-200 C and the predicate device share the same indication for use and similar technological characteristics.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds in flight, stacked vertically.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 3 2002
Mr. Ralf Benda W & H Dentalwerk Buermoos GmbH 53 Ignaz-Glazer-Strasse Buermoos, AUSTRIA 5111
Re: K014068
Trade/Device Name: elcoMed SA-200 115 (110-130 V), elcoMed SA 200 23 (220-240 V), elcoMed SA 200C 115 (100-130 V), elcoMed SA-200C 230 (220-240 V) Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: March 5, 2002 Received: March 7, 2002
Dear Mr. Benda:
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.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualled on that your device complies with other requirements mean that I DA has made a decembiations administered by other Federal agencies. of the Act of ally rederal statues and regisments, including, but not limited to: registration You must comply with an the Fee b requirement) and 801); good manufacturing practice allu listing (21 CFR Purt 067), labeling (21 CFR Part 820); and if requirements as set form in the quality by steams (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 I mis letter will anow you to ocelin manating your substantial equivalence of your device to 510(K) premiarket nourieation. The 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 If you desire specific at not 10. your in vitro diagnostic devices), please contact the and additionally 21 OF CF (101) 594-4613. Additionally, for questions on the promotion and Office of Comphance at (301) 591-1812 the Office of Compliance at (301) 594-4639. advertising or your aregulation entitled, "Misbranding by reference to premarket Also, prease note the regulations of the general information on your responsibilities under nonication (210) It it it it it it is of the Division of Small Manufacturers, International and the Act may be obtained from the Bounber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATION FOR USE
Verl 3 - 4/24/96
Applicant: W&H Dentalwerk Buermoos GmbH
510(k) Number (if known): not known yet
elcoMED SA-200 115 (100-130 V),elcoMED SA-200 230 Device Name: (220-240 V), elcoMED SA-200C 115 (100-130 V), elcoMED SA-200C 230 (220-240 V)
Indications For Use:
The Indications are very widespread in the field of oral surgery.
- A. Implant placement, including
-
- preparation of the osteotomy site
-
- bone reconturing, osteoplasty
-
- B. Bone grafting
-
- granns
- Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
-
- harvesting autogen living bone
-
- sinus elevation & grafting of alveolar sockets
-
- C. Removal and sectioning of teeth ant teeth bone for e.g. impacted third molars and complicated extractions
- D. Periodontal surgeries
-
- bone recontouring & alveoplasty around living teeth
-
- removal of exoslosis
-
- E. Endodontic treatment
-
- Intracanal preparations using rotating NiTi-files
-
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Surser Rumper
OR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter-Use (Optional Format 1-2-96)