510(k) clearances

PDR Airway Device

Park Dental Research Corp. · Dental

K262937Substantially EquivalentTraditionalLRK
Open FDA's page for this record
Third party flag
N
City
Ardmore
Advisory committee description
Dental
Address 1
2401 N. Commerce
Address 2
Suite E
Statement or summary
Summary
Product code
LRK
Zip code
73401
Applicant
Park Dental Research Corp.
Decision date
2026-10-20
Decision code
SESE
Country code
US
Device name
PDR Airway Device
Advisory committee
DE
Contact
Senthil Sampath
K number
K262937
State
OK
Date received
2026-08-21
Review advisory committee
DE
Postal code
73401
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Device, Anti-Snoring
Medical specialty description
Dental
Regulation number
872.5570
Device class
2
Registration number
3012716038, 3018094310, 3003460151, 1825660, 3008313791, 3010852338, 8010019, 3027346720, 1937100, 3005730680, 3000171384, 3009549393, 3038209294, 3002911411, 3039443708, 3003928050, 3031978086, 3017567754, 3015674959, 3009779268, 3008102163, 3011170140, 2031093, 3007233968, 3012539501, 3012728846, 3008763803, 3009401301, 3025306497, 3003496134, 3000126629, 3003283852, 3009440973, 3013652641, 3002706372, 3012359952, 3006650414, 3004964738, 3001295407, 3017520337 +68 more
FEI number
3012716038, 3018094310, 1825660, 3008313791, 3010852338, 3027346720, 1937100, 3005730680, 3000171384, 3009549393, 3038209294, 3002911411, 3001003585, 3039443708, 3003928050, 3031978086, 3017567754, 3003767844, 3015674959, 3009779268, 3008102163, 3011170140, 3007233968, 3012539501, 3012728846, 3008763803, 3001236549, 3009401301, 3025306497, 3003496134, 3000126629, 3003283852, 3003322666, 3009440973, 3013652641, 3002706372, 3004588608, 3012359952, 3006650414, 3004964738 +68 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.