FDA.reportPublic FDA data

Teeth protector, metal

Primary DI
04250381858639
Brand
Teeth protector, metal
Company
Spiggle & Theis Medizintechnik GmbH
Model
50-245-02
Catalog number
50-245-02
Device description
size 2, medium, with holes
Published
2022-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BRWProtector, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250381858639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250381858639042503818586394250381858639

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, reusableA prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags#

DUNS number
332893028
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250676736000Fiberglass light carrier50-231-0150-231-012025-09-15
04250676736024Fiberglass light carrier50-231-0350-231-032025-09-15
04250676736031Fiberglass light carrier50-234-0150-234-012025-09-15
04250676736055Fiberglass light carrier50-234-0350-234-032025-09-15
04250381858387Fiberglass light carrier for rigid and50-205-1250-205-122022-09-27
04250381858394Fiberglass lightcarrier for rigid and50-205-3650-205-362022-09-27
04250381858400Fiberglass lightcarrier for rigid and50-205-7050-205-702022-09-27
04250381858509Fiberglass lightcarrier for laser50-217-1250-217-122022-09-27
04250381858516Fibreglass light carrier for laser50-217-3650-217-362022-09-27
04250381858523Fiberglass lightcarrier for laser50-217-7050-217-702022-09-27
04250676736048Fiberglass light carrier50-234-0250-234-022022-09-27
04250676701800Fibre light carrier20-155-0020-155-002022-09-14
04250676748188Endoragard teeth protector50-240-0050-240-002026-04-27
04250676748195Medasil teeth protector50-250-0050-250-002022-09-27
04050659354647Brünings anastignatic aural magnifier10-180-0010-180-002026-01-21
04250676747204Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04250676747211Tray set with flex band1000617-31000617-32025-12-03
04250676747235Filter modul with 8 x LM10-845-0110-845-012025-12-03
04250676747228Tray set1000617-3-01000617-3-02025-12-03
04251993600128Filter modul with 8 x LM10-845-0110-845-012025-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676748188Endoragard teeth protectorSpiggle & Theis Medizintechnik GmbHBRW2026-04-27
08800017902289EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902296EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902302EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017901817EZ Bite blockDXM CO., LTDBRW2025-12-16
08800017900605EZ Bite blockDXM CO., LTDBRW2025-12-16
00194613123468MSI Precision Specialty InstrumentsMed Saver, Inc.BRW2025-08-01
08800142100949Tera Harz GuardGraphy Inc.BRW2025-07-18
00885797099365RMORmo, Inc.BRW2024-09-02
00885797099372RMORmo, Inc.BRW2024-09-02
00885797099396RMORmo, Inc.BRW2024-09-02
00885797099402RMORmo, Inc.BRW2024-09-02
00885797672278RMORmo, Inc.BRW2024-08-26
00885797672292RMORmo, Inc.BRW2024-08-26
00000008857972RMORmo, Inc.BRW2024-08-12
10889483007563SunMedSUNMED, LLCBRW2024-03-12
08800075604170OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604187OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604194OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
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