FDA.report

Amcop Bioactivator

Primary DI
EMICBC1DCM1
Brand
Amcop Bioactivator
Company
MICERIUM SPA
Model
BC1-DCM
Catalog number
BC1-DCM
Device description
Amcop Bioactivator BIOACTIVATOR 1 pc. Class I Mod. C DCM Size 1 - 45 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

Related Records

Product Codes

CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EMICBC1DCM1PrimaryHIBCC0

GMDN Terms

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

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

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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

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