Brace (Orafix Special)

FDA 510(k) K890290 · Norcliff Thayer, Inc.

Substantially Equivalent

510(k) numberK890290

Submission

Device name
Brace (Orafix Special)
Applicant
Norcliff Thayer, Inc.
Tarrytown, NY, US
Received
January 19, 1989
Decision date
March 29, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ECB – Unit, Syringe, Air And/Or Water
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code ECB

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K942519Uni-Syringe, Uni-Tip and Access Syringe TipsECB · Traditional Bull Frog Mfg. Co.08/23/1994SE
K931772Suretip Syringe Tip CoverECB · Traditional Western M/D, Inc.03/07/1994SE
K931137Dental Syringe TipECB · Traditional A-Dec, Inc.11/29/1993SE
K923876Riskontrol Single UseECB · Traditional Riskontrol04/05/1993SE
K923285Pro-Tip Disposable 3/1 Syringe NozzleECB · Traditional Smith & Nephew, Inc.09/15/1992SE
K920499Sani-TipECB · Traditional Dw Industries, Inc.05/03/1992SE
K911756Posterior Nasal Epistaxis InstrumentsECB · Traditional Richard Wolf Medical Instruments Corp.10/24/1991SE
K863024Seringa Triplice S.L.ECB · Traditional Sds Dental, Inc.09/25/1986SE
K854699Tubing SyringECB · Traditional Almore Intl., Inc.01/06/1986SE
K801686Spaceline Three Way SyringeECB · Traditional Pacific Dental Corp.08/04/1980SE

More from Pacific Dental Corp.

510(k)DeviceDecision
K791576Forget - Denture Bonding LiquidKOL · Traditional 10/26/1979SE
K780174OrabriteJER · Traditional 02/23/1978SE
K771002Ice BandIME · Traditional 08/30/1977SE

Questions and answers

When was Brace (Orafix Special) cleared by the FDA?

Brace (Orafix Special) (K890290) received a 510(k) decision of Substantially Equivalent on March 29, 1989, 69 days after the submission was received.

What is the product code of K890290?

The FDA product code is ECB – Unit, Syringe, Air And/Or Water, a Class I (low risk) device regulated under 21 CFR 872.4565.