FDA.reportPublic FDA data

Rodin

Primary DI
00810184450344
Brand
Rodin
Company
Pac-Dent, Inc.
Model
23864G
Device description
Rodin Denture Base 2.0 1.2kg - GL
Published
2026-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210189000Pac-Dent Denture Base ResinPac-Dent, Inc.2021-07-28EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810184450344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810184450344008101844503448101844503440810184450344

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Regulatory Flags#

DUNS number
080104787
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815967026143Rodin3DR-SGF2026-07-13
00815967029403Rodin238672026-07-13
00810184450146Rodin341102-12026-06-10
00815967029953Rodin240512026-05-26
00815967029960Rodin240522026-05-26
00810184451754Rodin341101-12026-05-20
00815967025887Rodin3DR-CNR-B1-12002026-05-20
00815967025894Rodin3DR-CNR-BL-12002026-05-20
00815967025900Rodin3DR-CNR-C2-12002026-05-20
00815967026112Rodin3DR-SPLINTF2026-05-20
00815967028116Rodin4711032026-05-20
00815967028123Rodin4811032026-05-20
00815967029045Rodin3DR-CNR-C1-6002026-05-19
00815967029052Rodin3DR-CNR-C1-3002026-05-19
00815967029069Rodin3DR-CNR-C1-12002026-05-19
00815967029076Rodin3DR-CNR-A3.5-6002026-05-19
00815967029083Rodin3DR-CNR-A3.5-3002026-05-19
00815967029090Rodin3DR-CNR-A3.5-12002026-05-19
00815967029106Rodin3DR-CNR-C3-6002026-05-19
00815967029113Rodin3DR-CNR-C3-3002026-05-19

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Primary DI, Brand, Company table
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06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078338major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078352major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30