FDA.reportPublic FDA data

Amcop Bioactivator

Primary DI
EMICB0S4DTMH1
Brand
Amcop Bioactivator
Company
MICERIUM SPA
Model
B0S4-DTMH
Catalog number
B0S4-DTMH
Device description
Amcop Bioactivator BIOACTIVATOR 1 pz. Classe I Mod. 0S DTM HARD Size4 - 60 mm
Published
2025-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMICB0S4DTMH1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436661136
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EMICCOSZ251Ena Etch ®COSZ25COSZ252025-12-18
EMICCHFFB0UNIVERSAL 1CHFFBCHFFB2025-04-23
EMICCHFFB1UNIVERSAL 1CHFFBCHFFB2025-04-23
EMICCU1BF0UNIVERSAL 1CU1BFCU1BF2025-04-11
EMICCU1BF1UNIVERSAL 1CU1BFCU1BF2025-04-11
EMICCU1OP0UNIVERSAL 1CU1OPCU1OP2025-04-11
EMICCU1OP1UNIVERSAL 1CU1OPCU1OP2025-04-11
EMICCU1UN0UNIVERSAL 1CU1UNCU1UN2025-04-11
EMICCU1UN1UNIVERSAL 1CU1UNCU1UN2025-04-11
EMICEHR1F0Ena HRI FlowEHR1FEHR1F2025-04-11
EMICEHR1F1Ena HRI FlowEHR1FEHR1F2025-04-11
EMICEHR2F0Ena HRI FlowEHR2FEHR2F2025-04-11
EMICEHR2F1Ena HRI FlowEHR2FEHR2F2025-04-11
EMICEHR5F0Ena HRI FlowEHR5FEHR5F2025-04-11
EMICEHR5F1Ena HRI FlowEHR5FEHR5F2025-04-11
EMICCPC0ENA CEM HFCPCCPC2025-04-03
EMICCPC1ENA CEM HFCPCCPC2025-04-03
EMICCPC30ENA CEM HFCPC-3CPC-32025-04-03
EMICCPC31ENA CEM HFCPC-3CPC-32025-04-03
EMICCPC3UD20ENA CEM HFCPC-3UD2CPC-3UD22025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611205742TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x0.76MM - 25UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAKMY2026-05-26
07908611205759TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x1MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAKMY2026-05-26
00815967029380RodinPac-Dent, Inc.KMY2026-03-23
00815967029397RodinPac-Dent, Inc.KMY2026-03-23
06974361422556Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422563Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422570Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422587Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423058Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423065Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423072Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423089Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
03770020010163FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010170FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010187FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
D775JAGFP0AccuguardGreat Lakes Dental Technologies, Ltd.KMY2026-01-16
28906139321169Taglus UltraLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321466Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321473Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321480Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321497Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321527Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321695Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321718Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321749Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321756Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321824Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321831Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321855Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321879Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09