FDA.report

Renamel® De-Mark™

Primary DI
D7797011DM0
Brand
Renamel® De-Mark™
Company
COSMEDENT, INC.
Model
7011DM
Catalog number
7011DM
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBDCoating, Filling Material, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7797011DM0PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
113911689
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 DIBrandModelCatalogPublished
D7796722B01Bulkfill6722B02022-03-08
D7796722C31Bulkfill6722C32022-03-08
D7796722D21Bulkfill6722D22022-03-08
D7796722351Bulkfill6722352022-03-01
D7796722A11Bulkfill6722A12022-03-01
D7796722A21Bulkfill6722A22022-03-01
D7796722A31Bulkfill6722A32022-03-01
D7796722B11Bulkfill6722B12022-03-01
D779203101116 Gauge Black Tips2031012021-11-11
D7792031021018 Gauge Pink Tips2031022021-11-11
D7792031031119 Gauge Silver Tips2031032021-11-11
D7792031041222 Gauge Black Tips2031042021-11-11
D77920320212Mixing Tips CosmeCore 8gTips2032022021-11-11
D77920320413MirrorImage 10:1 Tips2032042021-11-11
D77920320515Adhere 1:1 Tips2032052021-11-11
D77920320615Connect 4:1 Tips2032062021-11-11
D77920330211CosmeCore IntraOral Tips2033022021-11-11
D77920340213White Plastic Nozzle Tips2034022021-11-11
D77920350315CosmeCore 50g Tip Package2035032021-11-11
D77970351T1Impressiv 5:1 Putty Cartridge Tips70531T2021-11-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840479200910PRO SEALRELIANCE ORTHODONTIC PRODUCTS INCEBD2026-03-11
00840479202556LED PRO SEALRELIANCE ORTHODONTIC PRODUCTS INCEBD2026-03-11
00840479202563LED PRO SEALRELIANCE ORTHODONTIC PRODUCTS INCEBD2026-03-11
00840479200903PROSEALRELIANCE ORTHODONTIC PRODUCTS INCEBD2026-02-20
00840479203676LED ProSealRELIANCE ORTHODONTIC PRODUCTS INCEBD2025-08-05
00840479203683LED ProSealRELIANCE ORTHODONTIC PRODUCTS INCEBD2025-08-05
D7981PROSY0ProSealRELIANCE ORTHODONTIC PRODUCTS INCEBD2025-03-28
D798PROSY0ProSealRELIANCE ORTHODONTIC PRODUCTS INCEBD2025-03-28
EBREVLCOLBLACK9visio.lign color Blackbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLBLUE9visio.lign color Bluebredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLBODYA9visio.lign color Body Abredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLBODYB9visio.lign color Body Bbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLBODYC9visio.lign color Body Cbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLBODYD9visio.lign color Body Dbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLBROWN9visio.lign color Brownbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLCREME9visio.lign color Cremebredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLGLIGHT9visio.lign color Gum Lightbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLGPINK9visio.lign color Gum Pinkbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLGRED9visio.lign color Gum Redbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLGREYBL9visio.lign color Grey-Bluebredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLOLIVE9visio.lign color Olivebredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLORANGE9visio.lign color Orangebredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLROSE9visio.lign color Rosebredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLSET9visio.lign color Setbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLSKIT9visio.lign color Starter Kitbredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLWHITE9visio.lign color Whitebredent GmbH & Co. KGEBD2025-03-10
EBREVLCOLYELLOW9visio.lign color Yellowbredent GmbH & Co. KGEBD2025-03-10
EBREVLSHIELDHV59visio.lign shield HVbredent GmbH & Co. KGEBD2025-03-10
EBREVLSHIELDLV59visio.lign shield LVbredent GmbH & Co. KGEBD2025-03-10
J014647141980Signum liquidKulzer GmbHEBD2024-11-21