510(k) K110481
- Device
- TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
- Applicant
- ASI MEDICAL, INC.
- 510(k) number
- K110481
- Product code
- EIA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-05
- Date received
- 2011-02-18
- Regulation
- 872.6640
- Classification name
- Unit, Operative Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN MCPEEK
- Address
- 14550 E Easter Ave. Suite 700 Centennial CO US 80112 80112
FDA Registration Numbers#
- 3000190675
- 3038718579
- 1226003
- 3013237609
- 3003548115
- 9680845
- 9614446
- 3015967359
- 3003855981
- 9610617
- 3009774128
- 3006113289
- 1722638
- 2081055
- 2023950
- 1054713
- 3010373494
- 3007962015
- 3019103
- 1824362
- 3002819275
- 3003136642
- 1523530
- 3010141593
- 3013734432
- 2648666
- 3010707607
- 8044015
- 1062917
- 3003188647
- 3004884150
- 8030876
- 3008559238
- 3011326671
- 3017604
- 3015376465
- 3042256511
- 3011300255
- 3000219976
- 3003637274
- 3021551875
- 1018470
- 3030089804
- 3012421607
- 3006946348
- 3030126955
- 3007997036
- 3004082121
- 3022226
- 8044167
- 1017522
- 3010446656
- 3033509898
- 3015980207
- 1649995
- 9614977
- 3008344699
- 2520265
- 3009797758
- 3039246551
- 2020475
- 3010939897
- 3003917473
- 3004064895
- 3002564560
- 3010202439
- 9681829
- 3005938413
- 9681479
- 9710613
- 3007518359
- 8040233
- 8020994
- 2916440
- 3029780
- 3002807636
- 3008813313
- 3014980444
- 1319130
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EIA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251626 | Midmark Dental Delivery System | Midmark Corporation | 2025-11-03 |
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | 2025-07-17 |
| K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., | 2025-06-27 |
| K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | 2025-05-27 |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC | 2025-02-19 |
| K242404 | BDC Dental Unit | Bdc Dental Corporation , Ltd. | 2025-02-07 |
| K231297 | Firstar Dental Unit | Firstar Dental Company | 2025-01-27 |
| K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | 2024-09-03 |
| K240754 | N2 | Megagen Implant Co., Ltd. | 2024-03-21 |
| K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | 2024-02-28 |
| K202963 | ELEC Master, ELEC Master Dual | Mgnewton , Ltd. | 2023-05-05 |
| K211556 | N2 | Megagen Implant Co., Ltd. | 2023-04-05 |
| K213749 | G7, Dental Operative Unit and Accessories | Shinhung Company, Ltd. | 2023-04-03 |
| K220873 | Perceptive electric dental motor and control unit | Lares Research | 2022-12-15 |
| K213742 | Infinity Pro, Logic, Quality, Sprint | Olsen Indústria E Comércio S.A. | 2022-10-19 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases