Atlas FDA

CEREC 3

FDA 510(k) clearance K994172 · decided 2000-02-08

Clearance details

K-number
K994172
Device name
CEREC 3
Applicant
Sirona Dental Systems GmbH
Decision
Substantially Equivalent
Date received
1999-12-10
Decision date
2000-02-08
Days to decision
60 days
Clearance type
Special
Product code
ELW
Device class
2
Regulation number
872.3660
Medical specialty
Dental
Advisory committee
Dental
Location
North Attleboro, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.