FDA.reportPublic FDA data

Reicodent

Primary DI
00406164436103
Brand
Reicodent
Company
devemed GmbH
Model
02-ZRM 204SD C
Device description
Scaler # 204SD COMFORT | SL | double ended
Published
2020-04-08
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00406164436103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00406164436103004061644361034061644361030406164436103

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4974679491990info@devemed.de

Regulatory Flags#

DUNS number
506826739
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04061644035953Reicodent02-876-12 C2020-04-15
04061644036851Reicodent02-878-12 C2020-04-15
04061644065349Reicodent02-1086-41 C2020-12-29
04061644065356Reicodent02-1086-10 C2020-12-29
04061644065363Reicodent02-1086-11 C2020-12-29
04061644065370Reicodent02-1086-30 C2020-12-29
04061644065387Reicodent02-1086-31 C2020-12-29
04061644065394Reicodent02-1086-60 C2020-12-29
04061644065400Reicodent02-1086-61 C2020-12-29
04061644004058devemed720-1002020-04-21
04061644004072devemed725-32020-04-21
04061644004089devemed725-42020-04-21
04061644004355devemed790-12020-04-21
04061644004362devemed790-22020-04-21
04061644004379devemed790-32020-04-21
04061644004454devemed794-602020-04-21
04061644004461devemed794-612020-04-21
04061644004478devemed794-622020-04-21
04061644007646devemed794-3412020-04-21
04061644008667devemed793-AS-12020-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783006858Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006865Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006872Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006889Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006896Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006902Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006926Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006933Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006940Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006957Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006964Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007282Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007305Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007312Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007336Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007343Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007350Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007367Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007381Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007404Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007411Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007428Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007442Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007459Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
G149TBS204S01TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSAS1208TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSG171800TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSLADY02TBS DentalACME ENTERPRISE.EMN2026-03-02
10889950145590Hu_FriedyHU-FRIEDY MFG. CO., LLCEMN2026-01-30
10889950145569Hu_FriedyHU-FRIEDY MFG. CO., LLCEMN2026-01-22