FDA Registration
Active
🇺🇸 United States
with Light; HP21KL PRIME LINE; HP21NL PRIME LINE High Speed Handpiece with Light; HP21SL PRIME LINE High Speed; HP21WL P
Reg #: 3023861999
·
FEI: 3023861999
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FLIGHT DENTAL SYSTEMS USA INC.
- Registration Number
- 3023861999
- FEI Number
- 3023861999
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3103 Farrell Rd
- City
- Houston
- State
- TX
- ZIP
- 77073
- Country
- US
Regulatory Submissions
- 510(k) Number
- K032234
Owner / Operator
- Firm Name
- Flight Dental Systems USA Inc.
- Operator Number
- 10091848
- Address
- 3103 Farrell Road
- City
- Houston
- State
- TX
- Postal Code
- 77073
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2024-11-07 |
Proprietary Names
with Light; HP21KL PRIME LINE; HP21NL PRIME LINE High Speed Handpiece with Light; HP21SL PRIME LINE High Speed; HP21WL P
(6 pins); QC5116KW Quick Connector, 4 holes; QC6016K Quick Connector, 4 holes (6 pins); QC6016KW Quick
Light; HB21K BASIC LINE; HB21KL BASIC LINE High Speed Handpiece with Light; HB23K BASIC LINE High Speed Handpiece;
Conn
Connector, 4 holes (6 pins);; QC5016W Quick Connector, 4 holes (6 pins); QC5116K Quick Connector, 4 holes
Electric Motor System; HB15L BASIC LINE High Speed Handpiece with Light; HB16L BASIC LINE High Speed Handpiece with
High Speed Handpiece with Light; HP22KL PRIME LINE; HP22NL PRIME LINE High Speed Handpiece with Light;
4 holes (6 pins); QC5016KW Quick Connector, 4 holes (6 pins); QC5016NT Quick Connector, 4 holes (6 pins); QC5016SW Quick
11 Premium Service Oil; LU1022 Premium Service Oil; LU1031 Service Oil;; QC4014K Quick Connector, 4 holes; QC4014NT Quic
HE21KL ECO LINE High Speed Handpiece with Light; HE21N ECO LINE High Speed Handpiece; HE21NL ECO LINE High Speed; HE21SL
Connector, 4 holes (6 pins); QC6016NT Quick Connector, 4 holes; QC6016S Quick Connector, 4 holes (6 pins); QC6116K Quick
CLASSIC LINE High Speed Handpiece with Light; HC8021K PRIME LINE High Speed Handpiece; HE11 ECO LINE; HE12 ECO LINE
HE22K ECO LINE High Speed Handpiece; HE22KL ECO LINE High Speed Handpiece with Light; HE22N ECO LINE; HE22NL ECO LINE
AM0002 Airmotor, 2 holes, 2000 rpm; AM0004 Airmotor, 4 holes, 2000 rpm; AM0012 Airmotor, 2 holes, 2000 rpm; AM0014
Handpiece; HE20K ECO LINE High Speed Handpiece; HE20KL ECO LINE; HE21K ECO LINE High Speed Handpiece
High Speed Handpiece with Light; HE22W ECO LINE High Speed Handpiece;; HE22WL ECO LINE High Speed Handpiece
HE16L ECO LINE High Speed Handpiece with Light; HE17 ECO LINE High Speed Handpiece; HE17B ECO LINE; HE18 ECO LINE High
HC21K CLASSIC LINE High Speed Handpiece HC21KL CLASSIC LINE High Speed Handpiece with Light; HC22K CLASSIC LINE; HC22KL
HB23KL BASIC LINE; HC20K CLASSIC LINE High Speed Handpiece; HC20KL CLASSIC LINE High Speed Handpiece with Light
HE12 ECO LINE High Speed Handpiece; HE14 ECO LINE High Speed Handpiece; HE15L ECO LINE High Speed;
rpm; HB12 BASIC LINE High Speed Handpiece; HB14 BASIC LINE High Speed; EM-9001 Electric Motor System and EMB-9002
Connector, 4 holes; QC4014W Quick Connector, 4 holes; QC5015K Quick Connector, 4 holes QC5016K Quick Connector
ECO LINE High Speed Handpiece with Light; HE21W ECO LINE High Speed Handpiece; HE21WL ECO LINE High Speed;
Establishment Types
Repack or Relabel Medical Device