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Results for “3Shape”
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EUDAMED
43
FDA 510(k)
14
FDA PMA
GUDID
431
Country / market
European Union (all)
5
United States
444
More countries (1)
Denmark
5
Risk class
Class I
122
Class IIa
4
Class IIb
Class III
Class II (US)
321
More classes (11)
Class A
Class B
Class C
Class D
IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
Unclassified (FDA)
1
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448 devices found
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
3Shape Scan Bodies NAbox
3Shape TRIOS A/S
·
,
Denmark
Class I
GUDID
not on market
Withdrawn
GUDID
I
3Shape Scan Posts AS1.7
3Shape A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
3Shape Scan Bodies DXG
3Shape TRIOS A/S
·
,
Denmark
Class I
GUDID
on market
None
GUDID
I
Lab Scanner A49.I
3Shape A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
3Shape Scan Posts CYLsys
3Shape A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
3Shape Scan Bodies NBN
3Shape TRIOS A/S
·
,
Denmark
Class I
GUDID
on market
None
GUDID
I
3Shape Scan Bodies OTR
3Shape TRIOS A/S
·
,
Denmark
Class I
GUDID
on market
None
GUDID
I
Lab Scanner A39.OST
3Shape A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
Trios® 3 S2-3
3Shape TRIOS A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
Lab Scanner A38.I
3Shape A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
3Shape R850
3Shape A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
Trios® 3 PS1-1
3Shape TRIOS A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
Trios® 4 S3P-2
3Shape TRIOS A/S
·
,
Denmark
Class II
GUDID
on market
None
GUDID
II
3Shape Scan Posts CS1.00
3Shape A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
TRIOS 3 Calibration Tip
3Shape TRIOS A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
3Shape Dental System 2016-1
3Shape A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
Lab Scanner A42.I
3Shape A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
3Shape Scan Bodies ZTsys
3Shape TRIOS A/S
·
,
Denmark
Class I
GUDID
on market
None
GUDID
I
TRIOS® T12-Ctip
3Shape TRIOS A/S
·
,
Denmark
Class II
GUDID
not on market
Withdrawn
GUDID
II
Implant Studio 2017-1
3Shape Medical A/S
·
,
Denmark
(FDA 510(k) applicant)
Class II
GUDID
not on market
Withdrawn
GUDID
II
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Showing 181-200 of 448