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
Handpiece, Air-Powered, Dental EFB

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