ECLIPSE INTERACTIVE

Primary DI
D90946161116
Brand
ECLIPSE INTERACTIVE
Company
Ortho Arch Company Inc
Model
461-611
Catalog number
461-611
Device description
018 U2R ECLIPSE INTERACTIVE SLB MBT +8T (5)
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ECQAligner, Bracket, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECQAligner, Bracket, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D90946161116PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracketA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020956330
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D90927010916ORTHO ARCH270-1092025-09-29
D90927021918ORTHO ARCH270-2192025-09-29
D90943001914ORTHO ARCH430-0192025-09-29
D9094300201ORTHO ARCH430-0202025-09-29
D90992402115ORTHO ARCH924-0212025-09-29
D90992402216ORTHO ARCH924-0222025-09-29
D909924023G1ORTHO ARCH924-023G2025-09-29
D909924024G1ORTHO ARCH924-024G2025-09-29
D909924033F1ORTHO ARCH924-033F2025-09-29
D909924034F1ORTHO ARCH924-034F2025-09-29
D909924043F1ORTHO ARCH924-043F2025-09-29
D909924044F1ORTHO ARCH924-044F2025-09-29
D90992412116ORTHO ARCH924-1212025-09-29
D90992412217ORTHO ARCH924-1222025-09-29
D909924123G1ORTHO ARCH924-123G2025-09-29
D909924124G1ORTHO ARCH924-124G2025-09-29
D909924133F1ORTHO ARCH924-133F2025-09-29
D909924134F1ORTHO ARCH924-134F2025-09-29
D909924141F1ORTHO ARCH924-141F2025-09-29
D909924142F1ORTHO ARCH924-142F2025-09-29

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Primary DI, Brand, Company table
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G149TBSB1250TBS BASICSACME ENTERPRISE.ECQ2026-05-20
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00723896026854SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACKPRACTICON, INC.ECQ2024-08-07
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00723896026885SMILEGOODS ALIGNER CHEWIES UNSCENTED PRACTICON, INC.ECQ2024-08-07
00723896026892SMILEGOODS ALIGNER CHEWIES ASSORTED 24 PACKPRACTICON, INC.ECQ2024-08-07
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D90946300111ECLIPSE PASSIVE Ortho Arch Company IncECQ2023-06-20
D909270106103LINGUAL BUTTON Ortho Arch Company IncECQ2023-06-13
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D90927020210DIRECT BOND BUTTONOrtho Arch Company IncECQ2023-06-13