Atlas FDA

MODEL 410 DENTAL X-RAY FILM PROCESSORS

FDA 510(k) clearance K874118 · decided 1987-11-06

Clearance details

K-number
K874118
Device name
MODEL 410 DENTAL X-RAY FILM PROCESSORS
Applicant
Dent-X Co.
Decision
Substantially Equivalent
Date received
1987-10-09
Decision date
1987-11-06
Days to decision
28 days
Clearance type
Traditional
Product code
EGY
Device class
2
Regulation number
892.1900
Medical specialty
Radiology
Advisory committee
Radiology
Location
Elmsford, NY, 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
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) (K992896)Dental X-Ray Support Systems, Inc.1999-09-03
SMITH S-100 TIME & TEMPERATURE CONTROL (K955825)Smith Companies Dental Products1996-04-05
ALARA IMAGING SYSTEM (K955643)Denoptix, Inc.1996-03-01
PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (K945682)Gendex Corp.1995-02-09
AP201 DENTAL X-RAY FILM PROCESSOR (K900156)Allied Photo Products Co., Inc.1990-05-14
YOSHIDA AP 100 (K811211)Kaycor Intl., Ltd.1981-06-16
AUTO. DEVEL. UNIT FOO DENTAL X-RAY (K771433)Ada Products Co., Inc.1977-08-19
FILM PROCESSOR, AUTOMATIC (K770783)General Electric Co.1977-05-10

Recalls involving this device

No recalls on record reference this clearance.