FDA.reportPublic FDA data

Alice

Primary DI
00885797488985
Brand
Alice
Company
Rmo, Inc.
Model
C01005
Device description
ROTH ALICE CUSP MX 018L 11A 4MO
Published
2024-08-23
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
DYWBracket, Plastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885797488985PrimaryGS10
00000008857972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797488985008857974889858857974889850885797488985
00000008857972000000088579720000088579720000008857972

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
007058183
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885797644862TruLockJ040202024-08-23
00885797644879TruLockJ040212024-08-23
00885797664891TruLockJ040222024-08-23
00885797664907TruLockJ040232024-08-23
00885797664914TruLockJ040242024-08-23
00885797018403OrthonolA07408-12024-09-04
00885797526977FLI TwinM051502024-09-04
00885797019134ThermaloyA077102024-09-03
00885797099815TruFormK003292024-09-03
00885797099822TruFormK003302024-09-03
00885797099839TruFormK003312024-09-03
00885797099846TruFormK003322024-09-03
00885797099853TruFormK003332024-09-03
00885797099860TruFormK003342024-09-03
00885797099884RMOK004552024-09-03
00885797099891TruFormK005102024-09-03
00885797099907TruFormK005122024-09-03
00885797099914TruFormK005142024-09-03
00885797099921TruFormK005162024-09-03
00885797099938TruFormK005182024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82966101720900051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101720900101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101720900501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820000501Premium LineEC Certification Service GmbHDYW2026-06-09
D829661018200M0051Premium LineEC Certification Service GmbHDYW2026-06-09
D829661018200M0101Premium LineEC Certification Service GmbHDYW2026-06-09
D829661018200M0501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820900051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820900101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820900501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101920000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101920000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101920000501Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019200M0051Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019200M0101Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019200M0501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921000501Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019210M0051Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019210M0101Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019210M0501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921900051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921900101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921900501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966102020000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966102020000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966102020000501Premium LineEC Certification Service GmbHDYW2026-06-09