FDA.reportPublic FDA data

ULTIMENT

Primary DI
00841336100183
Brand
ULTIMENT
Company
Salvin Dental Specialties, Inc.
Model
ULTIMENT
Device description
SALVIN ULTI-MENT IMPLANT/CROWN AND BRIDGE CEMENT
Published
2015-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841336100183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336100183008413361001838413361001830841336100183

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113344790
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
00841336112032SalvinORAMEM-PLUS-15x202024-05-31
00841336112049SalvinORAMEM-PLUS-20x302024-05-30
00841336112056SalvinORAMEM-PLUS-30x402024-05-30
00841336111929SALVINOSS-BSALVINOSS-B-0.52024-05-27
00841336111936SALVINOSS-BSALVINOSS-B-1.02024-05-27
00841336111943SALVINOSS-BSALVINOSS-B-2.02024-05-27
00841336111950SALVINOSS-BSALVINOSS-B-4.02024-05-27
00841336111998SALVINOSS-BSALVINOSS-B-SYR-0.252024-05-27
00841336112001SALVINOSS-BSALVINOSS-B-SYR-0.502024-05-27
00841336112018SALVINOSS-BSALVINOSS-B-SYR-1.002024-05-27
00841336101760Salvin Stainless Steel UNC ProbePROBE-UNC2023-08-21
00841336103146Replacement Mallet Cap (Set of 2)MALLET-CAP2023-08-18
00841336103054#5 Front Surface Cone Socket Mirror - Box of 12MIRR-5-CS2023-08-16
00841336102675Flexible Stainless Steel Surgical Ruler - 6" (15.25cm)SURGRULER2023-08-11
00841336101128Salvin Adson Tissue Forcep-Curved-Serrated 4 3/4"ADSON-SERR-CURV2023-08-10
00841336101135Salvin Adson Titanium Curved Tissue Forceps 12cmADSON-TI-CURVED2023-08-10
00841336101142Salvin Bayonet Elevator Offset "In" - SmallBAYONET-ELEV-22023-08-10
00841336101159Salvin Debakey Atraumatic Tissue Forcep StraightDEBAKEY-STRAIGHT2023-08-10
00841336101166Salvin DEF 23 German Stainless Steel Extraction ForcepDEF 232023-08-10
00841336101173Salvin Serrated Elevator - 3mmDEL-SERR-32023-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967029472RodinPac-Dent, Inc.EMA2026-03-23
00815967029656RodinPac-Dent, Inc.EMA2026-03-23
00815967029663RodinPac-Dent, Inc.EMA2026-03-23
00815967029670RodinPac-Dent, Inc.EMA2026-03-23
00815967029687RodinPac-Dent, Inc.EMA2026-03-23
00815967029694RodinPac-Dent, Inc.EMA2026-03-23
00815967029700RodinPac-Dent, Inc.EMA2026-03-23
00815967029717RodinPac-Dent, Inc.EMA2026-03-23
00815967029724RodinPac-Dent, Inc.EMA2026-03-23
07290115050400High-Q-Bond SEB.J.M. LABORATORIES LTDEMA2026-03-20
00817169021438UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
00817169021445UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
00840479201566GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201573GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201580GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201597GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201603GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
09336472005450RIVA CEM AUTOMIXSDI LIMITEDEMA2026-02-16
09336472020965RIVA CEM AUTOMIXSDI LIMITEDEMA2026-02-16
09336472032203RIVA CEMSDI LIMITEDEMA2026-02-16
04560227803397iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803403iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803410iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803427iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803434iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803441iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803458iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803465iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803472iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803557iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09