Atlas FDA

HONIGUM

FDA 510(k) clearance K000878 · decided 2000-04-11

Clearance details

K-number
K000878
Device name
HONIGUM
Applicant
Dmg USA, Inc.
Decision
Substantially Equivalent
Date received
2000-03-20
Decision date
2000-04-11
Days to decision
22 days
Clearance type
Abbreviated
Product code
ELW
Device class
2
Regulation number
872.3660
Medical specialty
Dental
Advisory committee
Dental
Location
Ayer, MA, US
Third-party review
No
Expedited review
No

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

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Recalls involving this device

No recalls on record reference this clearance.