FDA.reportPublic FDA data

Rodin

Primary DI
00810184450146
Brand
Rodin
Company
Pac-Dent, Inc.
Model
341102-1
Device description
ProMin F Tooth Desensitizing Paste with Sodium Fluoride Tube Kit, 25g/tube, 2 tubes/box
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231060000ProMin Dental Desensitizing GelBelport Company, Inc., Gingi-Pak2024-06-13LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810184450146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810184450146008101844501468101844501460810184450146

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
080104787
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
00815967029120Rodin3DR-CNR-C3-12002026-05-19
00815967029137Rodin3DR-CNR-C4-6002026-05-19
00815967029144Rodin3DR-CNR-C4-3002026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E217149401ProphyProtectKettenbach GmbH & Co. KGEJR2026-06-08
EMICESA01Ena ShinyMICERIUM SPAEJR2025-11-07
EMICESB01Ena ShinyMICERIUM SPAEJR2025-11-07
00190707191177Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310236901089ProphyCare HApDirecta ABEJR2025-09-01
10304040192778Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
07615208479195VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479201VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479218VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479225VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479232VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479249VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208480054VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
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