FDA.reportPublic FDA data

Maarc dental - Articulating Paper

Primary DI
08906110440175
Brand
Maarc dental - Articulating Paper
Company
SHIVA PRODUCTS
Model
5521/001
Catalog number
5521/001
Device description
A diagnostic tool used in dentistry to highlight occlusal contacts and the distribution of occlusal forces. That is, it marks those points on the teeth where the teeth contact during biting and grinding.
Published
2024-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EFHPaper, Articulation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906110440175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906110440175089061104401758906110440175

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulation paperA strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
737988276
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906110440014MAARC DENTAL-Calahyd-RC9103/15x29103/15x22024-10-02
08906110440403MAARC DENTAL-Calx-O9102/1.5x29102/1.5x22024-10-02
08906110440007MAARC DENTAL-Sealmax - R8001/0018001/0012024-10-02
08906110440397MAARC DENTAL-Calcium Hydroxide Powder5002/100B5002/100B2024-10-02
08906110440458MAARC DENTAL - Ceraseal-B8501/0018501/0012024-10-02
08906110443039MAARC DENTAL -Rootfyx9107/0.5x49107/0.5x42024-10-02
08906110443053MAARC DENTAL - Sealmax + 8011/0018011/0012024-10-02
08906110443060MAARC DENTAL-Sealmax + 8011/0028011/0022024-10-02
08906110443145MAARC DENTAL-MTA Fast set kit8601/0018601/0012024-10-02
08906110443152MAARC DENTAL-MTA Fast set (unidose kit)8601/0028601/0022024-10-02
08906110443619MAARC DENTAL-Calcium Hydroxide Powder (with Barium Sulphate) 5002/015B5002/015B2024-10-02
08906110443732MAARC DENTAL - MTA Fast Set8601/0.58601/0.52024-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040600001ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
D040600011ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
D040600071ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
00889813062081Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062098Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062104Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062128Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062135Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062142Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062159Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062166Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062088Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062095Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062101Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062125Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062132Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062149Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062156Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062163Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062173Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
D956OCCLUFL0DSI Occlufoil 6mmD.S.I DENTAL SOLUTIONS LTDEFH2024-07-01
10732224001712Articulating PaperCROSSTEX INTERNATIONAL, INC.EFH2024-04-12
D040600081ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600130ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040602061ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600021ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
D040600031ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
D248720010"Madam Butterfly Silk 3/4"" Blue"HAGER WORLDWIDE, INC.EFH2023-05-15
D248720020"Madam Butterfly Silk 3/4"" Grn"HAGER WORLDWIDE, INC.EFH2023-05-15
D248720030"Madam Butterfly Silk 3/4"" Red"HAGER WORLDWIDE, INC.EFH2023-05-15