Atlas FDA

EASE (MODIFICATION TO)

FDA 510(k) clearance K771403 · decided 1977-08-22

Clearance details

K-number
K771403
Device name
EASE (MODIFICATION TO)
Applicant
L.D. Caulk Co.
Decision
Substantially Equivalent
Date received
1977-07-29
Decision date
1977-08-22
Days to decision
24 days
Clearance type
Traditional
Product code
EJJ
Device class
2
Regulation number
872.3070
Medical specialty
Dental
Advisory committee
Dental
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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FUTURA TOPCAP NON GAMMA-2 (K011801)Ab Ardent2001-08-16
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ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (K002808)Nordiska Dental AB2000-10-31
PARAGON (K991481)Lancer Orthodontics, Inc.1999-08-11
SECURALLOY (K982671)Specialites Septodont1998-10-19

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OMNIPLASTIC BONE CEMENT (N17113)L.D. Caulk Co.1981-09-16