FDA.reportPublic FDA data

Dandy Scan Body

Primary DI
05744003810000
Brand
Dandy Scan Body
Company
Coremedtech ApS
Model
BCP, ZimVie - Certain Ø3.4
Catalog number
80610166
Device description
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Published
2022-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05744003810000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05744003810000057440038100005744003810000

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4522660442contact@coremedtech.dk

Regulatory Flags#

DUNS number
306211589
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05744003810680Dandy Scan BodyDYU, Dentsply Sirona - Ankylos Unified Ø3.5-7.080610042023-05-11
05744003810697Dandy Scan BodyNCU, Neodent - Cone Morse Unified Ø3.75-5.080610022023-05-11
05744003810703Dandy Scan BodyNGU, Neodent - Grand Morse Unified Ø3.75-6.080610032023-05-11
05744003810017Dandy Scan BodyBCB, ZimVie - Certain Ø4.1806101672022-10-27
05744003810024Dandy Scan BodyBCY, ZimVie - Certain Ø5.0806101682022-10-27
05744003810031Dandy Scan BodyBCG, ZimVie - Certain Ø6.0806101692022-10-27
05744003810048Dandy Scan BodyBEP, ZimVie - External Ø3.25806101732022-10-27
05744003810055Dandy Scan BodyBEB, ZimVie - External Ø3.75806101742022-10-27
05744003810062Dandy Scan BodyBE4, ZimVie - External Ø4.0806101752022-10-27
05744003810079Dandy Scan BodyBEY, ZimVie - External Ø5.0806101762022-10-27
05744003810086Dandy Scan BodyBEG, ZimVie - External Ø6.0806101772022-10-27
05744003810093Dandy Scan BodyBI3, BioHorizons - Tapered Internal Ø3.0806101592022-10-27
05744003810109Dandy Scan BodyBIY, BioHorizons - Tapered Internal Ø3.5806101602022-10-27
05744003810116Dandy Scan BodyBIG, BioHorizons - Tapered Internal Ø4.5806101612022-10-27
05744003810123Dandy Scan BodyBIB, BioHorizons - Tapered Internal Ø5.7806101622022-10-27
05744003810130Dandy Scan BodyCCG, Camlog - Camlog Ø3.3806101812022-10-27
05744003810147Dandy Scan BodyCCY, Camlog - Camlog Ø3.8806101822022-10-27
05744003810154Dandy Scan BodyCCP, Camlog - Camlog Ø4.3806101832022-10-27
05744003810161Dandy Scan BodyCCB, Camlog - Camlog Ø5.0806101842022-10-27
05744003810185Dandy Scan BodyDAX, Dentsply Sirona - ASTRA TECH Ø3.0806101892022-10-27

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Primary DI, Brand, Company table
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