510(k) K831037
- Device
- AIR BURBINE HANDPIECE-DENTAL SCALING
- Applicant
- TACO DENTAL, INC.
- 510(k) number
- K831037
- Product code
- ELB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-05-09
- Date received
- 1983-03-31
- Regulation
- 872.4840
- Classification name
- Scaler, Rotary
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1648564
- 9613348
- 3006223010
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ELB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170596 | TN-Brush | Genoss Co., Ltd. | 2017-09-11 |
| K121114 | TIGRAN PERIBRUSH | Tigran Technologies AB | 2012-09-17 |
| K111724 | STRAUMANN TIBRUSH | Straumann USA | 2011-09-12 |
| K003640 | MINIENDO III | Sybron Dental Specialties, Inc. | 2001-02-22 |
| K782007 | ROTARY SCALER | Star Dental Mfg. Co. | 1979-01-03 |
Legacy Summary#
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FDA Review#
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