FDA.report

SCHWERT

Primary DI
E89640861220
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
4086-122
Catalog number
4086-122
Device description
Carving instr. for Composite
Published
2023-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E89640861220PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+49746498910700contact@schwert.com

Regulatory Flags

DUNS number
341195628
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
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
E89628870SCHWERT288728872025-12-16
E89617059007E0SCHWERT1705-90-07E1705-90-07E2025-09-04
E89617059101E0SCHWERT1705-91-01E1705-91-01E2025-09-04
E89617059206E0SCHWERT1705-92-06E1705-92-06E2025-09-04
E89617059303E0SCHWERT1705-93-03E1705-93-03E2025-09-04
E896294760SCHWERT29476294762025-06-10
E896294980SCHWERT29498294982025-06-10
E8964320SCHWERT4324322025-06-10
E896169520SCHWERT1695-21695-22025-05-19
E8965000260SCHWERT5000-265000-262025-04-08
E8965000270SCHWERT5000-275000-272025-04-08
E8965000280SCHWERT5000-285000-282025-04-08
E8965000540SCHWERT5000-545000-542025-04-08
E8961033610SCHWERT1033-611033-612025-04-07
E8961137170SCHWERT1137-171137-172025-04-07
E8961411040SCHWERT1411-041411-042025-04-07
E8961411060SCHWERT1411-061411-062025-04-07
E896169710007E0SCHWERT1697-100-07E1697-100-07E2025-04-07
E89616971TI06E0SCHWERT1697-1TI-06E1697-1TI-06E2025-04-07
E896170512007E0SCHWERT1705-120-07E1705-120-07E2025-04-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00817169029281Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEIY2026-03-05
00840018672628Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-11
00840018667167Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018667242Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018667464Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018671768Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018671775Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018665675Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018665804Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018665811Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666047Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666085Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666993Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018663381Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-04
00840018663626Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-04
00840018663190Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-29
00840018663213Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-29
00840018661622Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-28
00840018661639Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-28
07649988629341OdneFill Tips 25mmOdne AGEIY2025-09-03
05010058178083InstrapacROBINSON HEALTHCARE LIMITEDEIY2025-06-23
05010058178694InstrapacROBINSON HEALTHCARE LIMITEDEIY2025-06-19
00303620001434Septodont Multi-Use DispenserSEPTODONT SAS SPECIALITES SEPTODONTEIY2025-05-29
00766054002987Turbo-CRESSENTIAL DENTAL SYSTEMS, INC.EIY2025-04-04
00889813066898Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066904Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066911Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066928Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066935Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066942Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12