SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156— 510(k) K001463

Clearance details

Applicant

Davis Schottlander & Davis, Ltd.

Product code

Code EBI

Device class

Class 2

Regulation

21 CFR 872.3760

Advisory panel

Dental

Date received

2000-05-10

Decision date

2000-06-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kansas City, MO, US

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• K024252 — MATCH MASTER LOW FUSION PORCELAIN2004-01-22
• K024250 — MATCH PRESS PRESSABLE CERAMIC2003-08-25
• K993717 — ENIGMA HI-BASE DENTURE BASE MATERIAL1999-12-22
• K984134 — NATURA DENTURE TEETH1999-02-12
• K984128 — ENIGMA DENTURE TEETH1999-02-09

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →