FDA.reportPublic FDA data

ERGOPLANT

Primary DI
04038653427000
Brand
ERGOPLANT
Company
Aesculap AG
Model
DX535R
Catalog number
DX535R
Device description
ERGOPLANT BONE CONDENSER BAY.1.5-2.2
Published
2020-07-06
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
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653427000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653427000040386534270004038653427000

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be 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
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4160TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4170TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4180TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4190TBS BASICSACME ENTERPRISE.EKG2026-05-20
00348783012323Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKG2026-04-30
10889950147242Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147259Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147266Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147273Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147280Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147297Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147303Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147310Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147327Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147334Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147341Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147358Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147365Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147686Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147785Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147839Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147853Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147860Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147877Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950148447Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950148454Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
07898506843541QuinelatoSchobell Industrial LtdaEKG2022-12-08
07898506843657QuinelatoSchobell Industrial LtdaEKG2022-12-08
07899798200029QuinelatoSchobell Industrial LtdaEKG2022-12-08
10889950019129HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKG2020-11-12