Atlas FDA

Q3 DISPOSABLE PROPHY ANGLE

FDA 510(k) clearance K923980 · decided 1993-05-27

Clearance details

K-number
K923980
Device name
Q3 DISPOSABLE PROPHY ANGLE
Applicant
Q3 Special Products, Inc.
Decision
Substantially Equivalent
Date received
1992-08-07
Decision date
1993-05-27
Days to decision
293 days
Clearance type
Traditional
Product code
EGS
Device class
1
Regulation number
872.4200
Medical specialty
Dental
Advisory committee
Dental
Location
St. Louis, MO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (K251869)Premium Plus (Dongguan) Limited2025-09-15
Disposable Prophy Angle (K240950)Pacific Care Limited2025-05-28
Star E900 Handpiece Series (K240183)Dentalez, Inc., Stardental Division2024-09-19
General Cutting Straight (K230106)Nakanishi, Inc.2023-05-24
FX Contra (K222518)Nakanishi, Inc.2022-11-17
Smooth Drive contra angle and straight handpieces (K220874)Lares Research2022-11-07
Lotus Prophy Angle (K220346)Ajk Engineering, Inc.2022-11-07
Dental Handpiece, Model CA160, CA160L, and CA500L (K220577)Micro-Nx Co., Ltd.2022-07-29
SURGmatic S15 L Pro (K213139)Kavo Dental GmbH2021-12-21
General Cutting Contra Handpiece (K202960)Nakanishi, Inc.2020-10-27
TRAUS Dental Handpieces (K182892)Saeshin Precision Co., Ltd.2019-11-26
General Cutting Contra Handpiece (K182999)Nakanishi, Inc.2019-04-16

Recalls involving this device

No recalls on record reference this clearance.