Atlas FDA

TITANIUM SUCTION TIP

FDA 510(k) clearance K874401 · decided 1987-11-12

Clearance details

K-number
K874401
Device name
TITANIUM SUCTION TIP
Applicant
Implant Innovations International, Inc.
Decision
Substantially Equivalent
Date received
1987-10-28
Decision date
1987-11-12
Days to decision
15 days
Clearance type
Traditional
Product code
EHZ
Device class
1
Regulation number
872.6640
Medical specialty
Dental
Advisory committee
Dental
Location
West Palm Beach, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
IMTEC BONE COLLECTOR SYSTEM (K973248)Imtec Corp.1997-11-19
TAP EXPRESS EJECTOR (K941164)Tap Express, Inc.1994-05-18
SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR (K911072)A & F Products1991-05-15
OROSCOPE MODEL NUMBER COS-100 (K903718)Cygnus Instruments, Inc.1990-11-09
DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 (K892882)Nieusma R & D, Inc.1989-06-23
DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 (K892881)Nieusma R & D, Inc.1989-06-23
DRI-CLAVE LIQUID KLEENZALL (K880754)Columbus Dental Mfg. Co.1988-05-12
PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT (K873545)Commercial Products & Engineering Co.1987-11-20
VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER (K864621)Seldoren , Ltd.1987-02-13
EVACUATOR TIPS (K863769)The Medical Group, Inc.1986-10-30
SPACELINE HIGH VOLUME EVACUATION HANDPIE (K801682)Pacific Dental Corp.1980-08-04
MVS UNIT, MODEL SEU-8 AND DEU-8, 80 (K782068)Dentsply Intl.1979-01-26

Recalls involving this device

No recalls on record reference this clearance.